Back to results

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

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

bleomycin sulfate

filgrastim

pegfilgrastim

ABVD regimen

BEACOPP regimen

cyclophosphamide

dacarbazine

doxorubicin hydrochloride

etoposide

prednisone

procarbazine hydrochloride

vinblastine sulfate

vincristine sulfate

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Canberra Hospital
Nepean Cancer Care Centre at Nepean Hospital
Westmead Institute for Cancer Research at Westmead Hospital
Princess Alexandra Hospital
Peter MacCallum Cancer Centre
St. Vincent's Hospital - Melbourne
Royal Perth Hospital
Ziekenhuis Netwerk Antwerpen Middelheim
AZ Sint-Jan
Institut Jules Bordet
Hopital Universitaire Erasme
Cliniques Universitaires Saint-Luc
Centre Hospitalier Universitaire Brugmann
Centre Hospitalier Notre Dame - Reine Fabiola
Universitair Ziekenhuis Antwerpen
Algemeen Ziekenhuis Sint Lucas
Hopital de Jolimont
U.Z. Gasthuisberg
Centre Hospitalier Regional de la Citadelle
H. Hartziekenhuis - Roeselaere
Clinique Universitaire De Mont-Godinne
Tom Baker Cancer Centre - Calgary
Cross Cancer Institute at University of Alberta
CancerCare Manitoba
Centre Hospitalier De Dunkerque - CHD
Moncton Hospital
Doctor H. Bliss Murphy Cancer Centre
Nova Scotia Cancer Centre
Cancer Centre of Southeastern Ontario at Kingston General Hospital
London Regional Cancer Program at London Health Sciences Centre
Ottawa Hospital Regional Cancer Centre - General Campus
Northeastern Ontario Regional Cancer Centre
Edmond Odette Cancer Centre at Sunnybrook
Princess Margaret Hospital
Windsor Regional Cancer Centre at Windsor Regional Hospital
Hopital Charles Lemoyne
Maisonneuve-Rosemont Hospital
Hopital Notre-Dame du CHUM
CHUM - Hotel Dieu Hospital
McGill Cancer Centre at McGill University
Centre Hospitalier Universitaire de Quebec
Hopital du Saint-Sacrement - Quebec
Saskatoon Cancer Centre at the University of Saskatchewan
University Hospital Rebro
Thomayer's University Hospital
Centre Hospitalier d'Annecy
Centre Hospitalier de la Cote Basque
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Institut Bergonie
Polyclinique Bordeaux Nord Aquitaine
C.H. Bourg En Bresse
CHU de Caen
Polyclinique Du Parc
Centre Regional Francois Baclesse
Centre Hospitalier Regional de Chambery
Hopital d'Instruction des Armees Percy
Hopital Antoine Beclere
CHR Clermont Ferrand, Hotel Dieu
Hopital Louis Pasteur
Centre Hospitalier Sud Francilien - Site Corbeil
Centre Hospitalier Universitaire Henri Mondor
Hopital Du Bocage
Institut Prive de Cancerologie
Hopital Andre Mignot
Hopital Saint Antoine Lille
Centre Hospitalier Regional et Universitaire de Lille
Centre Hospital Regional Universitaire de Limoges
Centre Leon Berard
Hopital Edouard Herriot - Lyon
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Centre Hospitalier de Meaux
Centre Hospitalier Marc Jacquet
Hopital Notre-Dame de Bon Secours
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Centre Hospitalier de Mulhouse
Centre Antoine Lacassagne
Hopital de l'Archet CHU de Nice
Hotel Dieu de Paris
Institut Curie Hopital
Hopital Saint-Louis
Hopital Saint Antoine
CHU Pitie-Salpetriere
Hopital Cochin
Hopital Necker
Hopital Haut Leveque
Centre Hospitalier Lyon Sud
Hopital Rene Dubos
Institut Jean Godinot
Hopital Sud
Centre Henri Becquerel
Centre Rene Huguenin
CHU Sainte-Etienne - Hopital Bellevue
Hopital de Saint Germain-en-Laye
Hopital Universitaire Hautepierre
Hopital Foch
Centre Hospitalier Valence
Centre Hospitalier de Valenciennes
CHU de Nancy - Hopitaux de Brabois
Hopital Paul Brousse
Institut Gustave Roussy
National Institute of Oncology
HagaZiekenhuis - Locatie Leyenburg
Jeroen Bosch Ziekenhuis
Meander Medisch Centrum
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Onze Lieve Vrouwe Gasthuis
Academisch Medisch Centrum at University of Amsterdam
Reinier de Graaf Group - Delft
Medisch Spectrum Twente
University Medical Center Groningen
Atrium Medical Centre - Heerlen
Leiden University Medical Center
Academisch Ziekenhuis Maastricht
Universitair Medisch Centrum St. Radboud - Nijmegen
Saint Laurentius Ziekenhuis
Daniel Den Hoed Cancer Center at Erasmus Medical Center
University Medical Center Utrecht
Auckland City Hospital
Waikato Hospital
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
Hospital de la Santa Cruz i Sant Pau
Hospital Clinic de Barcelona
Hospital Universitari Germans Trias i Pujol
Sahlgrenska University Hospital
University Hospital of Linkoping
Lund University Hospital
Karolinska University Hospital - Huddinge
Umea Universitet
Uppsala University Hospital
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Raigmore Hospital
Kent and Canterbury Hospital
Hull Royal Infirmary
Kettering General Hosptial
Leicester Royal Infirmary
Middlesex Hospital
Mount Vernon Cancer Centre at Mount Vernon Hospital
Nottingham City Hospital NHS Trust
Cancer Research Centre at Weston Park Hospital
Staffordshire General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ABVD

BEACOPP

Arm Description

8 cycles of ABVD

4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline

Outcomes

Primary Outcome Measures

Event-free survival

Secondary Outcome Measures

Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma

Disease-free survival in patients with complete response

Overall survival

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

Full Information

NCT ID

NCT00049595

First Posted

November 12, 2002

Last Updated

December 19, 2022

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

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

1. Study Identification

Unique Protocol Identification Number

NCT00049595

Brief Title

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

Official Title

BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 2002 (Actual)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

4. Oversight

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

552 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABVD

Arm Type

Active Comparator

Arm Description

8 cycles of ABVD

Arm Title

BEACOPP

Arm Type

Experimental

Arm Description

4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline

Intervention Type

Biological

Intervention Name(s)

bleomycin sulfate

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Biological

Intervention Name(s)

pegfilgrastim

Intervention Type

Drug

Intervention Name(s)

ABVD regimen

Intervention Type

Drug

Intervention Name(s)

BEACOPP regimen

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

dacarbazine

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Type

Drug

Intervention Name(s)

prednisone

Intervention Type

Drug

Intervention Name(s)

procarbazine hydrochloride

Intervention Type

Drug

Intervention Name(s)

vinblastine sulfate

Intervention Type

Drug

Intervention Name(s)

vincristine sulfate

Primary Outcome Measure Information:

Title

Event-free survival

Time Frame

from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death

Secondary Outcome Measure Information:

Title

Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma

Time Frame

from randomization till end of treatment

Title

Disease-free survival in patients with complete response

Time Frame

from the day of first documentation of CR to the day of relapse

Title

Overall survival

Time Frame

from the date of randomization to the date of death

Title

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

Time Frame

from one week prior to randomization till 10 years after end of treatment or death

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: