Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00049595
First received: November 12, 2002
Last updated: June 13, 2014
Last verified: June 2014

November 12, 2002
June 13, 2014
August 2002
January 2010   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00049595 on ClinicalTrials.gov Archive Site
  • Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma [ Designated as safety issue: No ]
  • Disease-free survival in patients with complete response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Occurrence of secondary malignancies [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • 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
  • Active Comparator: ABVD
    8 cycles of ABVD
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: ABVD regimen
    • Drug: dacarbazine
    • Drug: doxorubicin hydrochloride
    • Drug: vinblastine sulfate
  • Experimental: BEACOPP
    4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
    Interventions:
    • Biological: bleomycin sulfate
    • Biological: filgrastim
    • Biological: pegfilgrastim
    • Drug: BEACOPP regimen
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: prednisone
    • Drug: procarbazine hydrochloride
    • Drug: vincristine sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
552
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Croatia,   Czech Republic,   France,   Hungary,   Netherlands,   New Zealand,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00049595
EORTC-20012, EORTC-20012, GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04, 2004-001558-10
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
  • 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
Study Chair: Patrice P. Carde, MD Gustave Roussy, Cancer Campus, Grand Paris
Study Chair: David C. Linch Middlesex Hospital
Study Chair: Marine Divine, MD Centre Hospitalier Universitaire Henri Mondor
Study Chair: Anna Sureda Hospital de la Santa Cruz i Sant Pau
Study Chair: Ralph M. Meyer, MD, FRCPC Margaret and Charles Juravinski Cancer Centre
Study Chair: David Ma, MD St. Vincent’s Hospital.
Study Chair: Devinder Gill, MD Princess Alexandra Hospital
Study Chair: Bengt Glimelius, MD Uppsala University Hospital
European Organisation for Research and Treatment of Cancer - EORTC
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP