Trial Information

Minimal Initial Therapy (MIT) for "Early" Supradiaphragmatic Hodgkin's Disease: A Multicenter Randomized Trial of Short Neoadjuvant Chemotherapy (VAPEC-B) Plus Involved Field Radiotherapy (MIT) Versus Mantle Radiotherapy

OBJECTIVES: I. Determine the recurrence rate and long term survival of patients with early
stage Hodgkin's disease given vincristine/doxorubicin/prednisolone/
etoposide/cyclophosphamide/bleomycin (VAPEC-B) chemotherapy and involved field radiation vs
mantle radiotherapy.

OUTLINE: This is a randomized multicenter study. Patients are randomized to receive either
vincristine/doxorubicin/prednisolone/etoposide/cyclophosphamide/ bleomycin (VAPEC-B)
chemotherapy and involved field radiotherapy or mantle radiotherapy only. Patients receiving
VAPEC-B are given prednisolone daily on weeks 1-6, doxorubicin IV along with
cyclophosphamide IV on week 1, doxorubicin IV and etoposide orally for 5 days on week 3, and
vincristine and bleomycin IV on weeks 2 and 4. Involved field radiotherapy is commenced at
week 6, within 14 to 21 days of the last chemotherapy treatment. Patients randomized to
receive mantle radiotherapy only are given treatments daily for 4 weeks. Patients are
followed every 3 months for the first two years, every 4 months for the third year, every 6
months for the fourth and fifth years and annually thereafter.

PROJECTED ACCRUAL: 400 patients will be accrued over 4-5 years.