Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 to 70	Other	SUMC-G5 NCI-V01-1671, NCT00026208

Objectives

1. 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.
2. 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.
3. 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.

Entry Criteria

Disease Characteristics:

• Diagnosis of stage I or IIA Hodgkin's lymphoma
  • Previously untreated disease
  • Eligible subtypes:
    • Nodular sclerosis
    • Mixed cellularity
    • 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

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

Patient Characteristics:

Age:

• 18 to 70

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 2,000/mm³
• Platelet count at least 150,000/mm³

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

Expected Enrollment

A total of 80 patients will be accrued for this study within 5 years.

Outcomes

Progression-free survival by Kaplan-Meier at completion of therapy and then annually for 3 years

Early and late treatment-related toxicity
Freedom from second disease progression by Kaplan-Meier
Overall survival by Kaplan-Meier at 5 and 10 years
Frequency of complete response by positron-emission tomography scan between weeks 4 and 5 of chemotherapy

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.

Trial Contact Information

Trial Lead Organizations

Stanford Cancer Center

Sandra Horning, MD, Protocol chair		Ph: 650-725-6456; 800-756-9000

U.S.A.
California
	Stanford
	Stanford Cancer Center
		Clinical Trials Office - Stanford Cancer Center	Ph:  650-498-7061
			Email: cctoffice@stanford.edu
		Sandra Horning, MD	Ph:  650-725-6456
	Vallejo
	Kaiser Permanente Medical Center - Vallejo
		Louis Fehrenbacher, MD	Ph:  707-651-2577

Registry Information
Official Title		Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study
Trial Start Date		2001-06-12
Trial Completion Date		2011-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00026208
Date Submitted to PDQ		2001-08-30
Information Last Verified		2009-06-30

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