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

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Medical Conditions
  • Lymphoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT00049595

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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; from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death
Secondary Outcome Measures
    Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma; from randomization till end of treatment; Disease-free survival in patients with complete response; from the day of first documentation of CR to the day of relapse; Overall survival; from the date of randomization to the date of death; 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; from one week prior to randomization till 10 years after end of treatment or death
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Hull Royal Infirmary
Hull
England
HU3 2KZ
Kettering General Hosptial
Kettering
England
NNI6 8UZ
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Staffordshire General Hospital
Stafford
England
ST16 3SA
Birmingham
B15 2TH
Nottingham
Nottinghamshire
NG5 1PB
Cancer Research Centre at Weston Park Hospital
England
S1O 2SJ
Middlesex Hospital
London
England
WC1E 6HX
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

12 Nov 2002

Date updated in source

05 Feb 2016