Lymphoma Clinical Trial
Official title:
Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
not yet known which combination chemotherapy regimen is more effective in treating patients
who have advanced Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different
combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.
OBJECTIVES:
- Compare relapse-free and overall survival of patients with previously untreated
advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide,
mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin,
bleomycin, vinblastine, and dacarbazine (ABVD).
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine
and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2
consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6,
8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63
followed by a taper on days 64-84. Treatment continues for 12 weeks.
- Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on
days 1 and 15. Treatment repeats every 28 days for 6-8 courses.
All patients achieving a complete remission or partial remission after chemotherapy undergo
involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal
masses at least 5 cm in diameter, or initial splenic disease.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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