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.

Condition	Treatment or Intervention	Phase
stage II adult Hodgkin's disease stage I adult Hodgkin's disease	Drug: bleomycin  Drug: cyclophosphamide  Drug: doxorubicin  Drug: etoposide  Drug: prednisolone  Drug: vincristine	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  16 Years   -   75 Years

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• No prior treatment

--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

South Africa
      Groote Schuur Hospital, Cape Town, Cape Town,  7925,  South Africa
United Kingdom
      Royal Preston Hospital, Preston,  PR2 9HT,  United Kingdom
United Kingdom, England
      Addenbrooke's NHS Trust, Cambridge,  England,  CB2 2QQ,  United Kingdom
      Bristol Oncology Centre, Bristol,  England,  BS2 8ED,  United Kingdom
      Bristol Royal Hospital for Sick Children, Bristol,  England,  BS2 8BJ,  United Kingdom
      Clatterbridge Centre for Oncology NHS Trust, MERSEYSIDE,  England,  L63 4JY,  United Kingdom
      Cookridge Hospital, Leeds,  England,  LS16 6QB,  United Kingdom
      Derbyshire Royal Infirmary, Derby,  England,  DE1 2QY,  United Kingdom
      Middlesex Hospital- Meyerstein Institute, London,  England,  W1G 3AA,  United Kingdom
      Mount Vernon Hospital, Northwood,  England,  HA6 2RN,  United Kingdom
      Newcastle General Hospital, Newcastle upon Tyne,  England,  NE4 6BE,  United Kingdom
      Norfolk & Norwich Hospital, Norwich,  England,  NR1 3SR,  United Kingdom
      Oxford Radcliffe Hospital, Oxford,  England,  0X3 9DU,  United Kingdom
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom
      Southend General Hospital, Westcliff-On-Sea,  England,  United Kingdom
      University Birmingham, Birmingham,  England,  B15 2TT,  United Kingdom
      University Hospitals of Leicester, Leicester,  England,  LE1 5WW,  United Kingdom
United Kingdom, Scotland
      Royal Hospital for Sick Children, Edinburgh,  Scotland,  United Kingdom

Study chairs or principal investigators

M. Williams,  Study Chair,  Medical Research Council   

Study ID Numbers:  CDR0000065522; MRC-UKLG-LY07; EU-97004
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002987
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08