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 Information

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

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.