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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Medical Research Council
- Enrollment
- 400
- Locations
- 35
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with radiation therapy alone in treating patients with early-stage Hodgkin's disease.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 16 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS: Histologically proven stage IA or IIA Hodgkin's disease without mediastinal bulk Patients with Hodgkin's disease existing below diaphragm only are not eligible
- •PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not HIV positive No prior malignancy other than basal cell carcinoma or cervical intraepithelial neoplasia
- •PRIOR CONCURRENT THERAPY: No prior treatment
Exclusion Criteria
- Not provided