Trial Outcomes & Findings for Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816) (NCT NCT00725010)

NCT ID: NCT00725010

Last Updated: 2015-09-09

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 64 participants
• Primary outcome timeframe: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
• Results posted on: 2015-09-09

Participant Flow

Participant milestones

Measure	Planned Temozolomide+Radiotherapy Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Overall Study STARTED	50
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Planned Temozolomide+Radiotherapy Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Overall Study Toxicity	9
Overall Study Tumor Progression	7
Overall Study Withdrawal by Subject	2
Overall Study Death	1
Overall Study Lost to Follow-up	1
Overall Study Hepatopathy probably not Temodal-related	1
Overall Study Suspect lymph nodes neck thorax abdomen	1
Overall Study No further documentation	1
Overall Study Intensified treatment scheme: 3 on 1 off	2

Baseline Characteristics

Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)

Baseline characteristics by cohort

Measure	Planned Temozolomide+Radiotherapy n=50 Participants Subjects with newly diagnosed Glioblastoma multiforme. Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.
Age, Continuous	57 years STANDARD_DEVIATION 12.06 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment Austria	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase

Outcome measures

Measure	Temozolomide+Radiotherapy n=44 Participants Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.	Temozolomide Alone n=6 Participants Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles.
Safety: Number of Adverse Events in the Indicated Categories Possibly Related to Temozolomide	14 Adverse Events	0 Adverse Events
Safety: Number of Adverse Events in the Indicated Categories Unlikely Related to Temozolomide	35 Adverse Events	1 Adverse Events
Safety: Number of Adverse Events in the Indicated Categories Probably Related to Temozolomide	22 Adverse Events	1 Adverse Events

PRIMARY outcome

Timeframe: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase

Outcome measures

Measure	Temozolomide+Radiotherapy n=44 Participants Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.	Temozolomide Alone n=6 Participants Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles.
Number of Participants Who Discontinued Due to Toxicity	8 Participants	1 Participants

Adverse Events

Temozolomide+Radiotherapy

Serious events: 8 serious events

Other events: 12 other events

Deaths: 0 deaths

Temozolomide Alone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Temozolomide+Radiotherapy n=44 participants at risk Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.	Temozolomide Alone n=6 participants at risk Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles.
Blood and lymphatic system disorders Pancytopenia	4.5% 2/44 • Number of events 2	16.7% 1/6 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	4.5% 2/44 • Number of events 2	0.00% 0/6
General disorders General physical health deterioration	2.3% 1/44 • Number of events 1	0.00% 0/6
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	2.3% 1/44 • Number of events 1	0.00% 0/6
Nervous system disorders Dural fistula	2.3% 1/44 • Number of events 1	0.00% 0/6
Nervous system disorders Status epilepticus	2.3% 1/44 • Number of events 1	0.00% 0/6
Vascular disorders Deep vein thrombosis	2.3% 1/44 • Number of events 1	0.00% 0/6

Other adverse events

Measure	Temozolomide+Radiotherapy n=44 participants at risk Participants with newly diagnosed Glioblastoma multiforme who received temozolomide + radiotherapy during the combined therapy phase (per-protocol treatment). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks during the concomitant treatment phase. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles during the monotherapy phase. Radiotherapy consisted in fractionated focal irradiation at a dose of 2 Gy per fraction given Monday through Friday for a total dose of 60 Gy, administered with temozolomide during the concomitant treatment phase.	Temozolomide Alone n=6 participants at risk Participants with newly diagnosed Glioblastoma multiforme treated with temozolomide alone (despite the study plan, 6 participants only received temozolomide and no radiotherapy; results are presented separately for these 6 participants). Temozolomide was administered orally once daily at 75 mg/m\^2 with radiotherapy for 6 weeks. After four weeks, temozolomide was administered at 150 mg/m\^2 to 200 mg/m\^2 from Day 1 to Day 5 of six therapy cycles.
Blood and lymphatic system disorders Leukopenia	11.4% 5/44 • Number of events 5	0.00% 0/6
Blood and lymphatic system disorders Thrombocytopenia	15.9% 7/44 • Number of events 8	0.00% 0/6
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/44	16.7% 1/6 • Number of events 1
Skin and subcutaneous tissue disorders Rash	6.8% 3/44 • Number of events 7	0.00% 0/6

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place