|
|
Phase III Randomized Study of Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) Versus Doxorubicin, Vinblastine, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone (Stanford V) With or Without Radiotherapy in Patients With Locally Extensive or Advanced Hodgkin's Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase III | Treatment | Closed | 16 and over | ECOG-2496 CAN-NCIC-HD7, CALGB-59905, SWOG-E2496, E2496, NCT00003389, HD7 |
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.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: - Prior corticosteroids allowed
Radiotherapy: Surgery: Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC at least 4,000/mm3 (unless documented bone marrow
involvement)
- Platelet count at least 100,000/mm3 (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
Expected Enrollment 850A total of 850 patients will be accrued for this study within 4.3 years. Outcomes Primary Outcome(s)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
Overall progression-free survival by two-sided 0.05 level logrank test 5 and 10 years following study completion
Secondary Outcome(s)Pulmonary function by forced vital capacity and DLCO at baseline and 5 years following study completion Second cancers Reproductive function by Reproductive Health Assessment questionnaire, semen analysis, follicle-stimulating hormone, and luteinizing hormone at baseline and 5 years following study completion Deaths from causes other than Hodgkin's disease 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 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
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.
Trial Contact Information
Trial Lead Organizations Eastern Cooperative Oncology Group | | | Sandra Horning, MD, Protocol chair | | Ph: 650-725-6456; 800-756-9000 |
| |
Southwest Oncology Group | | | Richard Fisher, MD, Protocol chair | | | |
NCIC-Clinical Trials Group | | | Joseph Connors, MD, Protocol chair | | | |
Cancer and Leukemia Group B | | | Nancy Bartlett, MD, Protocol chair | | Ph: 314-362-5654; 800-600-3606 |
| |
Registry 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 | | Trial Start Date | | 2000-11-06 | | Registered in ClinicalTrials.gov | | NCT00003389 | | Date Submitted to PDQ | | 1998-06-24 | | Information Last Verified | | 2006-07-03 | | NCI Grant/Contract Number | | CA21115 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
|