Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
- Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's
lymphoma with a favorable prognosis treated with Stanford V-C chemotherapy comprising
cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and
etoposide with low-dose radiotherapy.
- Minimize the early and late effects of treatment in these patients by avoiding staging
laparotomy and its consequences, limiting cumulative doses of chemotherapy, and
reducing the dose of radiotherapy to moderately bulky sites of disease.
- Assess early and late treatment-related toxicity, freedom from second disease
progression, and overall survival at 5 and 10 years in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30-60 minutes
weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on
weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1-8; vincristine IV and
bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60
minutes on days 1 and 2 of weeks 3 and 7. Beginning 2-3 weeks after completion of
chemotherapy, patients undergo low-dose radiotherapy 5 days a week for approximately 3
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival by Kaplan-Meier
at completion of therapy and then annually for 3 years
Kaiser Permanente Medical Center
United States: Food and Drug Administration
|Stanford University School of Medicine||Stanford, California 94305-5317|
|Kaiser Permanente Medical Center||Vallejo, California 94589|