Clinical trial NCT00002987: Combination Chemotherapy Given With Radiation Therapy or Radiation Therapy Alone in Treating Patients With Early-Stage Hodgkin's Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-04-06
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital, Cape Town
city: Birmingham
country: United Kingdom
facility: University Birmingham
state: England
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Sick Children
state: England
city: Bristol
country: United Kingdom
facility: Bristol Oncology Centre
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's NHS Trust
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Leeds
country: United Kingdom
facility: Cookridge Hospital
state: England
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: England
city: London
country: United Kingdom
facility: Middlesex Hospital- Meyerstein Institute
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: England
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich Hospital
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend General Hospital
state: England
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Michael Williams, MD
role: STUDY_CHAIR
References:
citation: 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. [Abstract] Eur J Haematol 73 (Suppl 65): A-E08, 39, 2004.