Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma | Not Recruiting
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

Trial Source

There is no location for this trial

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Health Conditions
  • Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT00049595
Primary Trial ID Number
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.
Research Details
  • OBJECTIVES: - Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine. - Compare complete response, disease-free survival, and overall survival of patients treated with these regimens. - Compare quality of life of patients treated with these regimens. - Compare occurrence of second malignancies in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Score (3 vs 4 or more) and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8 courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence of disease progression or unacceptable toxicity. - Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM, vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of therapy, and then annually for 10 years. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : bleomycin sulfate, Biological : filgrastim, Biological : pegfilgrastim, Drug : ABVD regimen, Drug : BEACOPP regimen, Drug : cyclophosphamide, Drug : dacarbazine, Drug : doxorubicin hydrochloride, Drug : etoposide, Drug : prednisone, Drug : procarbazine hydrochloride, Drug : vinblastine sulfate, Drug : vincristine sulfate

Study Arm Groups : ABVD, BEACOPP, BEACOPP, BEACOPP, ABVD, BEACOPP, BEACOPP, ABVD, ABVD, BEACOPP, BEACOPP, BEACOPP, BEACOPP, ABVD, BEACOPP

Intervention Type
See Interventions above
Primary Outcome Measures
  • Event-free survival; null
Secondary Outcome Measures
  • Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma; null; Disease-free survival in patients with complete response; null; Overall survival; null; Quality of life as assessed by European Organization for Research of the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 version 3.0; null; Occurrence of secondary malignancies; null
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
16 Years - 60 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Histologically confirmed Hodgkin's lymphoma
  • - No lymphocyte predominant, nodular type (nodular paragranuloma)
  • - Clinical stage III or IV disease
  • - At least 1 bidimensionally measurable target lesion or extranodal lesion
  • - International Prognostic Score of at least 3
  • PATIENT CHARACTERISTICS:
  • Age
  • - 16 to 60
  • Performance status
  • - WHO 0-2
  • Life expectancy
  • - Not specified
  • Hematopoietic
  • - WBC greater than 2,000/mm^3
  • - Platelet count greater than 100,000/mm^3
  • Hepatic
  • - No prior uncontrolled hepatitis B viral infection
  • - Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)
  • Renal
  • - Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)
  • Cardiovascular
  • - No severe cardiac disease that would limit normal life expectancy or preclude study
  • - LVEF at least 50%
  • Pulmonary
  • - No severe pulmonary disease that would limit normal life expectancy or preclude study
  • - Respiratory function at least 30%
  • Other
  • - HIV negative
  • - HTLV1 negative
  • - No severe active infection
  • - No severe neurological or metabolic disease that would limit normal life expectancy
  • or preclude study
  • - No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
  • situ of the cervix
  • - No psychological, familial, sociological, or geographical condition that would
  • preclude study
  • - Not pregnant or nursing
  • - Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • - Not specified
  • Chemotherapy
  • - Not specified
  • Endocrine therapy
  • - Not specified
  • Radiotherapy
  • - No concurrent radiotherapy
  • Surgery
  • - Not specified
  • Other
  • - No prior therapy for Hodgkin's lymphoma
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
University College London
London
WC1E 6HX
Birmingham
B15 2TH
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Nottingham University Hospitals, City Campus
Nottingham
NG5 1PB
Staffordshire General Hospital
Stafford
England
ST16 3SA
Kettering General Hosptial
Kettering, Northants
England
NNI6 8UZ
Hull Royal Infirmary
Hull
HU3 2KZ
Research Site
Northwood
Middlesex
HA6 2RN
Weston Park Hospital
Sheffield
England
S1O 2SJ
Kent and Canterbury Hospital
Canterbury
England
CT2 7NR
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, Croatia, Czech Republic, France, Hungary, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom
Scientific Title
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
EudraCT Number
Not available for this trial
Funder(s)
  • Lymphoma Trials Office
  • Lymphoma Study Association
  • Grup per l'Estudi dels Limfomes de Catalunya i Balears
  • NCIC Clinical Trials Group
  • Australasian Leukaemia and Lymphoma Group
  • Nordic Lymphoma Group
Other Study ID Numbers
EORTC-20012
Sponsor(s)
European Organisation for Research and Treatment of Cancer - EORTC
Key Dates

Recruitment Start Date

Aug 2002

Recruitment End Date

Jan 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

12 Nov 2002

Last Updated

13 Jun 2014