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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
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:
National Cancer Institute (NCI) Identifier:
First received: November 12, 2002
Last updated: November 2, 2010
Last verified: June 2009

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.

Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 550
Study Start Date: August 2002
Detailed Description:


  • 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.


Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 16 to 60

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • WBC greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • No prior uncontrolled hepatitis B viral infection
  • Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)


  • Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)


  • No severe cardiac disease that would limit normal life expectancy or preclude study
  • LVEF at least 50%


  • No severe pulmonary disease that would limit normal life expectancy or preclude study
  • Respiratory function at least 30%


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No concurrent radiotherapy


  • Not specified


  • No prior therapy for Hodgkin's lymphoma
  Contacts and Locations
Please refer to this study by its identifier: NCT00049595

  Show 140 Study Locations
Sponsors and Collaborators
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
Investigator: 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
Investigator: David Ma, MD St. Vincent’s Hospital.
Investigator: Devinder Gill, MD Princess Alexandra Hospital
Study Chair: Bengt Glimelius, MD Uppsala University Hospital
  More Information

Additional Information:
No publications provided Identifier: NCT00049595     History of Changes
Other Study ID Numbers: CDR0000258125, EORTC-20012, GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04
Study First Received: November 12, 2002
Last Updated: November 2, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult lymphocyte depletion Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists processed this record on April 15, 2014