Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
18 Years
70 Years
Both
Lymphoma, Hodgkin Disease, Lymphoma, Hodgkin Disease, Lymphoma: Hodgkin
Trial Information
Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
OBJECTIVES:
- 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
regimen.
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
weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 5 years.
Inclusion Criteria:
DISEASE CHARACTERISTICS:- Diagnosis of stage I or IIA Hodgkin's lymphoma
- Previously untreated disease
- Eligible subtypes:
1. Nodular sclerosis
2. Mixed cellularity
3. Classical, not otherwise specified
- No lymphocyte-predominant Hodgkin's lymphoma
- No mediastinal mass that is one-third or more of the maximum intrathoracic diameter
on a standing posterior chest x-ray
- No lymph node mass more than 10 cm in greatest transaxial diameter
- No more than 1 extranodal site of disease
- No constitutional (B) symptoms present at diagnosis
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 2,000/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
Renal:
- Creatinine no greater than 2 mg/dL
Cardiovascular:
- Ejection fraction at least 50% for patients over age 50 or with a history of cardiac
disease
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior or concurrent malignancy within the past 5 years except basal cell
skin cancer
- No other medical contraindication to study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior endocrine therapy
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational drugs
- No other concurrent antineoplastic therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival by Kaplan-Meier
Outcome Time Frame:
at completion of therapy and then annually for 3 years
Safety Issue:
No
Principal Investigator
Louis Fehrenbacher
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kaiser Permanente Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
LYMHD0002
NCT ID:
NCT00026208
Start Date:
June 2001
Completion Date:
May 2015
Related Keywords:
- Lymphoma, Hodgkin Disease
- Lymphoma
- Hodgkin Disease
- Lymphoma: Hodgkin
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Stanford University School of Medicine | Stanford, California 94305-5317 |
| Kaiser Permanente Medical Center | Vallejo, California 94589 |
