Trial Outcomes & Findings for Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma (NCT NCT00026208)
NCT ID: NCT00026208
Last Updated: 2018-07-24
Results Overview
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
up to 3 years
Results posted on
2018-07-24
Participant Flow
Participant milestones
| Measure |
Stanford V-C + Low-dose Radiotherapy
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
4
|
|
Overall Study
COMPLETED
|
71
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Stanford V-C + Low-dose Radiotherapy
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Overall Study
Complications of auto accident
|
1
|
0
|
Baseline Characteristics
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=72 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=93 Participants
|
4 participants
n=4 Participants
|
76 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsPopulation: Does not include those participants whose treatment was significantly modified due to accidental injury; or who were lost-to-follow-up.
Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=70 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Progression-free Survival (PFS)
|
89.7 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: Participants, for whom a PET-CT scan was not conducted in week 4 to 5 of treatment, were not included.
The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT).
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=38 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Frequency of Complete Response
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 30 days of treatmentEarly treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment.
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=72 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Early Treatment-related Toxicity
|
422 treatment-related adverse events
|
24 treatment-related adverse events
|
SECONDARY outcome
Timeframe: 16 yearsLate treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis.
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=72 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Late Treatment-related Toxicity
Hypothyroidism
|
19 treatment-related adverse events
|
0 treatment-related adverse events
|
|
Late Treatment-related Toxicity
Second Cancer
|
2 treatment-related adverse events
|
0 treatment-related adverse events
|
SECONDARY outcome
Timeframe: 16 yearsPopulation: Data to confirm Hodgkin's disease 2nd progression was not available for some participants.
Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis.
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=69 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Second Hodgkin's Disease Progression
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 yearsPopulation: Includes all participants, except those whose treatment was significantly modified due to accidental injury. Subjects who became lost-to-follow-up were censored at their last known value.
Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation.
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=71 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Overall Survival (OS)
|
10.4 years
Interval 0.7 to 15.5
|
13.2 years
Interval 1.8 to 13.9
|
SECONDARY outcome
Timeframe: 5 and 10 yearsPopulation: For overall survival at 5 and 10 years, this analysis does not include those participants known to be alive, but whose diagnosis was less than 5 or 10 years prior to current date or last date known alive, respectively.
Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints.
Outcome measures
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=69 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 Participants
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Survival at 5 and 10 Years
5 years
|
67 Participants
|
3 Participants
|
|
Survival at 5 and 10 Years
10 years
|
41 Participants
|
3 Participants
|
Adverse Events
Stanford V-C + Low-dose Radiotherapy
Serious events: 25 serious events
Other events: 72 other events
Deaths: 7 deaths
Stanford V-C Only
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=72 participants at risk
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 participants at risk
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
23.6%
17/72 • Number of events 17 • 16 years
|
50.0%
2/4 • Number of events 2 • 16 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second cancer
|
2.8%
2/72 • Number of events 2 • 16 years
|
0.00%
0/4 • 16 years
|
|
Injury, poisoning and procedural complications
Crush injury, automobile accident
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Fever
|
6.9%
5/72 • Number of events 6 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
Other adverse events
| Measure |
Stanford V-C + Low-dose Radiotherapy
n=72 participants at risk
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.
|
Stanford V-C Only
n=4 participants at risk
"Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
* Vincristine: 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8
* Cyclophosphamide: 650 mg/m², on week 1 and 5
* Doxorubicin: 25 mg/m², on week 1, 3, 5, 7
* Prednisone: 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² mg every other day during last 2 weeks of chemotherapy
* Bleomycin: 5 u/m² intravenously (IV) on week 2, 4, 6, 8
* Etoposide: 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)
|
|---|---|---|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Investigations
Lymphocyte count decreased
|
76.4%
55/72 • Number of events 101 • 16 years
|
100.0%
4/4 • Number of events 11 • 16 years
|
|
General disorders
Fatigue/Malaise
|
80.6%
58/72 • Number of events 58 • 16 years
|
75.0%
3/4 • Number of events 3 • 16 years
|
|
General disorders
Fever
|
4.2%
3/72 • Number of events 3 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
5.6%
4/72 • Number of events 4 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Metallic Taste in Mouth
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Dry Mouth
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Blood and lymphatic system disorders
Infection with grade 3 ANC grade 2 ATT (no hospitalization)
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Oral Mucositis
|
9.7%
7/72 • Number of events 7 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Mild Oral Sensitivity
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Oral Toxicity
|
11.1%
8/72 • Number of events 8 • 16 years
|
0.00%
0/4 • 16 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
2/72 • Number of events 2 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Epigastric pain
|
36.1%
26/72 • Number of events 26 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
Vascular disorders
Acute Pulmonary Embolism
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Insomnia
|
37.5%
27/72 • Number of events 27 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Tenderness at the PICC site
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Discomfort, burning & increased sensitivity
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
PICC line removed
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Nausea
|
70.8%
51/72 • Number of events 51 • 16 years
|
50.0%
2/4 • Number of events 2 • 16 years
|
|
Gastrointestinal disorders
Constipation
|
55.6%
40/72 • Number of events 40 • 16 years
|
75.0%
3/4 • Number of events 3 • 16 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
55.6%
40/72 • Number of events 40 • 16 years
|
75.0%
3/4 • Number of events 3 • 16 years
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
2.8%
2/72 • Number of events 2 • 16 years
|
0.00%
0/4 • 16 years
|
|
Psychiatric disorders
Depression
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Psychiatric disorders
Anxiety
|
4.2%
3/72 • Number of events 3 • 16 years
|
0.00%
0/4 • 16 years
|
|
Psychiatric disorders
Mood Alteration
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Chest soreness and tightness
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Infections and infestations
Fungal rash
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Infections and infestations
Infection
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/72 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
Renal and urinary disorders
Blood spotting
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Renal and urinary disorders
Gross hematuria
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Investigations
Neutrophil count decreased
|
56.9%
41/72 • Number of events 48 • 16 years
|
50.0%
2/4 • Number of events 3 • 16 years
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Nervous system disorders
Syncopal episode with brief loss of consciousness
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/72 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
Nervous system disorders
Altered taste sensation
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Vascular disorders
Vein Pain
|
8.3%
6/72 • Number of events 6 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
5/72 • Number of events 5 • 16 years
|
0.00%
0/4 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Pain, bilateral arms
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain, inflammation of left arm above IV site
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Aches and pains
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain, axilla & breast
|
0.00%
0/72 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
Gastrointestinal disorders
Heartburn
|
1.4%
1/72 • Number of events 1 • 16 years
|
50.0%
2/4 • Number of events 2 • 16 years
|
|
General disorders
Sorness in upper and lower extremities
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
4.2%
3/72 • Number of events 3 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Substernal chest pressure
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Pain, bone and muscle
|
5.6%
4/72 • Number of events 4 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain, abdominal
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Nervous system disorders
Headache
|
1.4%
1/72 • Number of events 1 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
General disorders
Pain, jaw
|
2.8%
2/72 • Number of events 2 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain, hips and legs
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Gas pains
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Joint pains, back and hips
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Ache and heaviness in left arm
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Vascular disorders
Phlebitis
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain, right groin
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain
|
4.2%
3/72 • Number of events 3 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Generalized achiness
|
2.8%
2/72 • Number of events 2 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Flu-like symptoms
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Pain, related to PICC
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Pain, lower back
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
2.8%
2/72 • Number of events 2 • 16 years
|
0.00%
0/4 • 16 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Skin and subcutaneous tissue disorders
Swelling
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
18/72 • Number of events 18 • 16 years
|
25.0%
1/4 • Number of events 1 • 16 years
|
|
General disorders
Weight loss
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
Nervous system disorders
Dizziness
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
|
General disorders
Chills
|
1.4%
1/72 • Number of events 1 • 16 years
|
0.00%
0/4 • 16 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place