Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments bleomycin sulfate, abvd regimen, stanford v regimen, cyclophosphamide, dacarbazine, doxorubicin hydrochloride, etoposide, mechlorethamine hydrochloride, prednisone, vinblastine, vincristine sulfate, radiation therapy
Phase phase 3
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date November 2000
Trial size 850 participants
Trial identifier NCT00003389, CALGB-59905, CAN-NCIC-HD7, CDR0000066386, ECOG-2496, SWOG-E2496

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Failure-free survival as measured by two-sided 0.05 level logrank test at completion of therapy and then every 6 months for 3 years
time frame:
Overall progression-free survival by two-sided 0.05 level logrank test 5 and 10 years following study completion
time frame:

Secondary Outcomes

Measure
Pulmonary function by forced vital capacity and DLCO at baseline and 5 years following study completion
time frame:
Second cancers
time frame:
Reproductive function by Reproductive Health Assessment questionnaire, semen analysis, follicle-stimulating hormone, and luteinizing hormone at baseline and 5 years following study completion
time frame:
Deaths from causes other than Hodgkin's disease
time frame:
Corr. new EBV detect. tech. in plasma and tumor tissue w/ cytotoxic T-cell response to EBV antigens and antigens from other viruses before study tx, at 1 wk, at 1 mo. after compl. of tx, & 1 year from study entry
time frame:
Corr. new EBV detect. tech. in plasma and tumor tiss. w/ impact of chemotherapy and/or radiotherapy on T-cell responses to EBV ags and ags from other viruses before study tx, at 1 wk, at 1 mo. after compl. of tx, & 1 year from study entry
time frame:

Eligibility Criteria

Male or female participants at least 16 years old.

DISEASE CHARACTERISTICS: - Histologically proven previously untreated classical Hodgkin's lymphoma of the following subtypes: - Nodular sclerosis - Mixed cellularity - Lymphocyte depletion - Lymphocyte rich - The following stages are eligible: - Stage I-IIA/B with massive mediastinal adenopathy - Stage III or IV - Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 (unless documented bone marrow involvement) - Platelet count at least 100,000/mm^3 (unless documented bone marrow involvement) Hepatic: - Bilirubin no greater than 5.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior corticosteroids allowed Radiotherapy: - No prior radiotherapy Surgery: - Prior surgery allowed

Additional Information

Official title A Randomized Phase III Trial of ABVD Versus Stanford V(+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease Without High Risk Features
Description OBJECTIVES: - Compare the failure-free survival of patients with locally extensive or advanced Hodgkin's lymphoma treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs doxorubicin, vinblastine, vincristine, bleomycin, mechlorethamine, etoposide, and prednisone (Stanford V) with or without radiotherapy. - Compare the overall survival and freedom from progression in these patients at 5 and 10 years after treatment with these regimens. - Compare pulmonary function, incidence of second cancers, reproductive function, and deaths from causes other than Hodgkin's lymphoma in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to number of adverse risk factors (0-2 vs 3-7) and disease characteristics (locally extensive vs advanced). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine IV on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy. - Arm II: Patients receive Stanford V chemotherapy comprising doxorubicin and vinblastine IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide IV); etoposide IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study within 4.3 years.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Eastern Cooperative Oncology Group.