Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002987
• Other study ID #: CDR0000065522
• Secondary ID: MRC-UKLG-LY07EU-
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 3, 2013
• Start date: January 1997

Study information

• Verified date: March 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• bleomycin sulfate

Drug:
• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• prednisolone

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital, Cape Town	Cape Town
United Kingdom	University Birmingham	Birmingham	England
United Kingdom	Bristol Oncology Centre	Bristol	England
United Kingdom	Bristol Royal Hospital for Sick Children	Bristol	England
United Kingdom	Addenbrooke's NHS Trust	Cambridge	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	University Hospitals of Leicester	Leicester	England
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk & Norwich Hospital	Norwich	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Royal Marsden Hospital	Sutton	England
United Kingdom	Southend General Hospital	Westcliff-On-Sea	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Countries where clinical trial is conducted

South Africa,  United Kingdom, 

References & Publications (1)

Radford JA, Williams MV, Hancock BW, et al.: Minimal initial chemotherapy plus involved field radiotherapy (RT) vs. mantle field RT for clinical stage IA/IIA supra-diaphragmatic Hodgkin's disease (HD). Results of the UK Lymphoma Group LY07 trial. [Abstrac