Trial Outcomes & Findings for Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma (NCT NCT00278408)

NCT ID: NCT00278408

Last Updated: 2025-08-26

Results Overview

Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 700 participants
• Primary outcome timeframe: Each patient will be observed for 3 years starting from completion of treatment.
• Results posted on: 2025-08-26

Participant Flow

From 02nd January 2006, to 16th November 2015, 700 patients were enrolled at 148 sites including hospitals and private practitioners.

Participant milestones

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Overall Study STARTED	81	81	155	150	114	114
Overall Study COMPLETED	77	79	133	135	110	109
Overall Study NOT COMPLETED	4	2	22	15	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Total n=695 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=81 Participants	0 Participants n=81 Participants	0 Participants n=155 Participants	0 Participants n=150 Participants	0 Participants n=114 Participants	0 Participants n=114 Participants	0 Participants n=695 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=81 Participants	81 Participants n=81 Participants	155 Participants n=155 Participants	150 Participants n=150 Participants	114 Participants n=114 Participants	114 Participants n=114 Participants	695 Participants n=695 Participants
Age, Categorical >=65 years	0 Participants n=81 Participants	0 Participants n=81 Participants	0 Participants n=155 Participants	0 Participants n=150 Participants	0 Participants n=114 Participants	0 Participants n=114 Participants	0 Participants n=695 Participants
Age, Continuous	43 years n=81 Participants	45 years n=81 Participants	46 years n=155 Participants	44 years n=150 Participants	50 years n=114 Participants	49 years n=114 Participants	47 years n=695 Participants
Sex: Female, Male Female	32 Participants n=81 Participants	38 Participants n=81 Participants	69 Participants n=155 Participants	67 Participants n=150 Participants	43 Participants n=114 Participants	43 Participants n=114 Participants	292 Participants n=695 Participants
Sex: Female, Male Male	49 Participants n=81 Participants	43 Participants n=81 Participants	86 Participants n=155 Participants	83 Participants n=150 Participants	71 Participants n=114 Participants	71 Participants n=114 Participants	403 Participants n=695 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
3 Years Event-free Survival	51 Participants	56 Participants	126 Participants	123 Participants	89 Participants	92 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
3 Years Progression-free Survival	64 Participants	68 Participants	133 Participants	136 Participants	96 Participants	104 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Overall survival was defined as the time from randomization to death of any cause.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
3 Years Overall Survival	76 Participants	74 Participants	144 Participants	141 Participants	107 Participants	108 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Rate of Complete Remissions and Progressive Disease Rate of complete remissions	64 Participants	64 Participants	141 Participants	133 Participants	109 Participants	105 Participants
Rate of Complete Remissions and Progressive Disease Rate of progressive disease	4 Participants	2 Participants	4 Participants	6 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Population: Only patients who reached a CR/CRu after at least 2 months after the final restaging examination were taken for the relapse analysis.

Relapse is defined as, recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or a marked increase in lymphoma manifestation size by more thyn 25% after at least 2 months CR or CRu from the time point of the final restaging examination

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=64 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=64 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=142 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=133 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=110 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=105 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Number of Patients With a Relapse After a CR/CRu	12 Participants	8 Participants	13 Participants	9 Participants	18 Participants	7 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Population: The number analyzed differs from overall number analyzed due to missing data.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) rate of secondary neoplasm	4 Participants	1 Participants	7 Participants	4 Participants	8 Participants	8 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Leukocytopenia CTC 3 - 4	31 Participants	22 Participants	45 Participants	36 Participants	21 Participants	21 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Thrombocytopenia CTC 3 - 4	3 Participants	3 Participants	3 Participants	0 Participants	2 Participants	1 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Anemia CTC 3 - 4	1 Participants	3 Participants	9 Participants	10 Participants	2 Participants	11 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Nausea CTC 3 - 5	1 Participants	5 Participants	7 Participants	5 Participants	1 Participants	3 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Vomiting CTC 3 - 5	1 Participants	3 Participants	4 Participants	2 Participants	2 Participants	1 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Diarrhoe CTC 3 - 5	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Constipation CTC 3 - 5	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants	2 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Mucositis CTC 3 - 5	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Arrhythmia CTC 3 - 5	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Cardiac functions CTC 3 - 5	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Sensory CTC 3 - 5	3 Participants	4 Participants	10 Participants	4 Participants	3 Participants	8 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Mood CTC 3 - 5	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Allergy CTC 3 - 5	2 Participants	4 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin) Infection CTC 3 - 5	6 Participants	12 Participants	13 Participants	15 Participants	8 Participants	12 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median) Absolute dose vincristine	12 mg Interval 2.0 to 13.0	12 mg Interval 2.0 to 12.0	12 mg Interval 2.0 to 13.0	12 mg Interval 4.0 to 12.0	12 mg Interval 2.0 to 12.0	12 mg Interval 2.0 to 12.0
Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median) Absolute dose prednisone	3000 mg Interval 500.0 to 5750.0	3000 mg Interval 400.0 to 3750.0	3000 mg Interval 500.0 to 3900.0	3000 mg Interval 1000.0 to 3900.0	3000 mg Interval 1000.0 to 6000.0	3000 mg Interval 500.0 to 4000.0

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Population: The number analyzed differs from overall number analyzed due to missing data.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion antibiotics interventional per patient	21 Participants	25 Participants	42 Participants	39 Participants	22 Participants	36 Participants
Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion red blood cell and platelet transfusions per patient	1 Participants	9 Participants	5 Participants	14 Participants	4 Participants	16 Participants

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Adherence to Protocol - Total Duration of Chemotherapy in Days (Median)	105 days Interval 20.0 to 126.0	70 days Interval 69.0 to 99.0	105 days Interval 102.0 to 124.0	71 days Interval 14.0 to 111.0	105 days Interval 21.0 to 137.0	70 days Interval 14.0 to 112.0

SECONDARY outcome

Timeframe: Each patient will be observed for 3 years starting from completion of treatment.

Outcome measures

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 Participants Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 Participants Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 Participants Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 Participants Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 Participants Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 Participants Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median) Cyclophosphamide	4474 mg/m² Interval 750.0 to 4693.0	4482 mg/m² Interval 738.0 to 4875.0	4464 mg/m² Interval 762.0 to 4750.0	4474 mg/m² Interval 1480.0 to 4667.0	4476 mg/m² Interval 1364.0 to 4737.0	4455 mg/m² Interval 742.0 to 4714.0
Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median) Doxorubicin	300 mg/m² Interval 50.0 to 316.0	300 mg/m² Interval 50.0 to 323.0	299 mg/m² Interval 48.0 to 316.0	298 mg/m² Interval 90.0 to 314.0	298 mg/m² Interval 91.0 to 318.0	298 mg/m² Interval 50.0 to 314.0
Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median) Rituximab	2244 mg/m² Interval 350.0 to 2438.0	2232 mg/m² Interval 375.0 to 2413.0	2238 mg/m² Interval 371.0 to 2500.0	2245 mg/m² Interval 740.0 to 2402.0	2242 mg/m² Interval 682.0 to 2520.0	2228 mg/m² Interval 389.0 to 2471.0

Adverse Events

Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication

Serious events: 17 serious events

Other events: 49 other events

Deaths: 7 deaths

Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication

Serious events: 17 serious events

Other events: 58 other events

Deaths: 7 deaths

Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication

Serious events: 43 serious events

Other events: 98 other events

Deaths: 15 deaths

Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication

Serious events: 41 serious events

Other events: 82 other events

Deaths: 11 deaths

Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication

Serious events: 30 serious events

Other events: 41 other events

Deaths: 10 deaths

Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication

Serious events: 27 serious events

Other events: 65 other events

Deaths: 11 deaths

Serious adverse events

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 participants at risk Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 participants at risk Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 participants at risk Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 participants at risk Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 participants at risk Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 participants at risk Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Infections and infestations Life-threatening infections	2.5% 2/81 • Number of events 2 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/81 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.65% 1/155 • Number of events 1 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.3% 2/150 • Number of events 2 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/114 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/114 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Cardiac disorders Severe Cardiomyopathy	0.00% 0/81 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/81 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/155 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.67% 1/150 • Number of events 1 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/114 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/114 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) secondary neoplasia	4.9% 4/81 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.2% 1/81 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.5% 7/155 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.7% 4/150 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	7.0% 8/114 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	7.0% 8/114 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
General disorders unplanned hospitalisation (emergency case)	12.3% 10/81 • Number of events 14 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	17.3% 14/81 • Number of events 17 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	18.1% 28/155 • Number of events 36 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	18.0% 27/150 • Number of events 37 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	14.9% 17/114 • Number of events 20 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	14.0% 16/114 • Number of events 25 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
General disorders other	1.2% 1/81 • Number of events 2 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.5% 2/81 • Number of events 2 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.5% 7/155 • Number of events 7 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.7% 7/150 • Number of events 7 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.4% 5/114 • Number of events 5 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.6% 3/114 • Number of events 3 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.

Other adverse events

Measure	Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication n=81 participants at risk Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication n=81 participants at risk Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication n=155 participants at risk Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication n=150 participants at risk Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim	Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication n=114 participants at risk Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate	Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication n=114 participants at risk Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. rituximab cyclophosphamide doxorubicin hydrochloride prednisone vincristine sulfate filgrastim
Gastrointestinal disorders Nausea CTC 3-5	1.3% 1/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	6.7% 5/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.7% 7/148 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	3.6% 5/138 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.95% 1/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.7% 3/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Gastrointestinal disorders Vomiting CTC 3-5	1.4% 1/74 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.0% 3/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.7% 4/148 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.5% 2/137 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.9% 2/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.89% 1/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Gastrointestinal disorders Diarrhoe CTC 3-5	0.00% 0/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.3% 1/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.3% 2/149 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.72% 1/139 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.89% 1/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Cardiac disorders Arrhythmia CTC 3-5	0.00% 0/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/74 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/149 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.4% 2/141 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.9% 2/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Cardiac disorders Cardiac functions CTC 3-5	0.00% 0/73 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/72 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.67% 1/149 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.4% 2/138 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Nervous system disorders Sensory CTC 3-5	4.0% 3/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	5.3% 4/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	6.7% 10/150 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.8% 4/141 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.9% 3/103 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	7.2% 8/111 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Infections and infestations Infection CTC 3-5	7.6% 6/79 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	15.4% 12/78 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	8.6% 13/152 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	10.4% 15/144 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	7.6% 8/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	10.6% 12/113 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Gastrointestinal disorders Constipation CTC 3-5	1.3% 1/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/74 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.4% 2/148 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.4% 2/139 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.8% 2/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Infections and infestations Mucositis CTC 3-5	0.00% 0/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	1.3% 1/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/149 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.71% 1/140 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.7% 3/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Psychiatric disorders Mood CTC 3-5	0.00% 0/74 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.68% 1/148 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/139 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.89% 1/112 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Immune system disorders Allergy CTC 3-5	2.7% 2/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	5.3% 4/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.67% 1/149 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.2% 3/139 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/105 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.88% 1/113 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Blood and lymphatic system disorders Leukocytopenia CTC 3, 4	72.1% 31/43 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	50.0% 22/44 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	59.2% 45/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	43.4% 36/83 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	42.9% 21/49 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	38.2% 21/55 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Blood and lymphatic system disorders Thrombocytopenia CTC 3, 4	3.9% 3/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	4.0% 3/75 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.1% 3/142 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.00% 0/137 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.0% 2/99 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	0.97% 1/103 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.
Blood and lymphatic system disorders Anemia CTC 3, 4	1.3% 1/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	3.9% 3/76 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	6.2% 9/145 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	7.4% 10/136 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	2.0% 2/100 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.	10.6% 11/104 • Each patient will be observed for at least 3 years starting from completion of treatment. Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5. The number analyzed differs from overall number analyzed due to missing data.

Additional Information

Dr. Viola Poeschel

Saarland University Medical School

Phone: +4968411615014

Email: dshnhl@uks.eu

Results disclosure agreements

• Principal investigator is a sponsor employee Regarding publications the PIs and the sponsor will be in understanding between considering the publication arrangement of the trial protocol. This only serves the optimization of the research activity and the security of the results for the community.
• Publication restrictions are in place

Restriction type: OTHER