Suspended

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

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What is being tested

bleomycin sulfate

+ cyclophosphamide

+ doxorubicin hydrochloride

BiologicalDrugRadiation
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

From 16 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 1997
See protocol details

Summary

Principal SponsorMedical Research Council
Last updated: December 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002987
Principal SponsorMedical Research Council
Last updated: December 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeHodgkin DiseaseLymphoma

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Groote Schuur Hospital, Cape Town

Cape Town, South AfricaOpen Groote Schuur Hospital, Cape Town in Google Maps

University Birmingham

Birmingham, United Kingdom

Bristol Royal Hospital for Sick Children

Bristol, United Kingdom

Bristol Oncology Centre

Bristol, United Kingdom
Suspended18 Study Centers