Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: bleomycin sulfateBiological: filgrastimDrug: ABVD regimenBiological: pegfilgrastimDrug: BEACOPP regimen
- Registration Number
- NCT00049595
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 552
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABVD dacarbazine 8 cycles of ABVD ABVD doxorubicin hydrochloride 8 cycles of ABVD ABVD vinblastine sulfate 8 cycles of ABVD BEACOPP bleomycin sulfate 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP filgrastim 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP pegfilgrastim 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP BEACOPP regimen 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline ABVD bleomycin sulfate 8 cycles of ABVD ABVD ABVD regimen 8 cycles of ABVD BEACOPP doxorubicin hydrochloride 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP etoposide 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP prednisone 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP procarbazine hydrochloride 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP vincristine sulfate 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP cyclophosphamide 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
- Primary Outcome Measures
Name Time Method Event-free survival from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (140)
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Clinique Universitaire De Mont-Godinne
🇧🇪Yvoir, Belgium
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Nepean Cancer Care Centre at Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
St. Vincent's Hospital - Melbourne
🇦🇺Fitzroy, Victoria, Australia
AZ Sint-Jan
🇧🇪Brugge, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Algemeen Ziekenhuis Sint Lucas
🇧🇪Ghent, Belgium
Centre Hospitalier Universitaire Brugmann
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Centre Hospitalier Notre Dame - Reine Fabiola
🇧🇪Charleroi, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Hopital de Jolimont
🇧🇪Haine Saint Paul, Belgium
Centre Hospitalier Regional de la Citadelle
🇧🇪Liege, Belgium
H. Hartziekenhuis - Roeselaere
🇧🇪Roeselare, Belgium
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Doctor H. Bliss Murphy Cancer Centre
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Centre Hospitalier De Dunkerque - CHD
🇨🇦Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Edmond Odette Cancer Centre at Sunnybrook
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Windsor Regional Cancer Centre at Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
CHUM - Hotel Dieu Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Hopital du Saint-Sacrement - Quebec
🇨🇦Quebec City, Quebec, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Centre Hospitalier de la Cote Basque
🇫🇷Bayonne, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Thomayer's University Hospital
🇨🇿Prague, Czechia
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Institut Bergonie
🇫🇷Bordeaux, France
C.H. Bourg En Bresse
🇫🇷Bourg En Bresse, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre Hospitalier Regional de Chambery
🇫🇷Chambery, France
Hopital d'Instruction des Armees Percy
🇫🇷Clamart, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Hopital Antoine Beclere
🇫🇷Clamart, France
CHR Clermont Ferrand, Hotel Dieu
🇫🇷Clermont-Ferrand, France
Hopital Du Bocage
🇫🇷Dijon, France
Centre Hospitalier Sud Francilien - Site Corbeil
🇫🇷Corbeil, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Hospitalier Regional et Universitaire de Lille
🇫🇷Lille, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Hospital Regional Universitaire de Limoges
🇫🇷Limoges, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Centre Hospitalier Marc Jacquet
🇫🇷Melun, France
Centre Hospitalier de Meaux
🇫🇷Meaux, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hotel Dieu de Paris
🇫🇷Paris, France
Hopital de l'Archet CHU de Nice
🇫🇷Nice, France
Hopital Saint-Louis
🇫🇷Paris, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Necker
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Hopital Sud
🇫🇷Rennes, France
CHU Sainte-Etienne - Hopital Bellevue
🇫🇷Saint Etienne, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Hopital de Saint Germain-en-Laye
🇫🇷Saint Germain-en-Laye, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Centre Hospitalier de Valenciennes
🇫🇷Valenciennes, France
Hopital Paul Brousse
🇫🇷Villejuif, France
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Reinier de Graaf Group - Delft
🇳🇱Delft, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Atrium Medical Centre - Heerlen
🇳🇱Heerlen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Saint Laurentius Ziekenhuis
🇳🇱Roermond, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hospital de la Santa Cruz i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
Lund University Hospital
🇸🇪Lund, Sweden
Karolinska University Hospital - Huddinge
🇸🇪Stockholm, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Raigmore Hospital
🇬🇧Birmingham, England, United Kingdom
Kettering General Hosptial
🇬🇧Kettering, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Hopital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Boucher, France
Polyclinique Du Parc
🇫🇷Caen, France
CHU de Caen
🇫🇷Caen, France
Hopital Saint Antoine Lille
🇫🇷Lille, France
Institut Curie Hopital
🇫🇷Paris, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Hopital Cochin
🇫🇷Paris, France
Hopital Foch
🇫🇷Suresnes, France
CHU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
HagaZiekenhuis - Locatie Leyenburg
🇳🇱's-Gravenhage, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Sahlgrenska University Hospital
🇸🇪Gothenburg (Goteborg), Sweden
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
🇵🇱Warsaw, Poland
Hospital Universitari Germans Trias i Pujol
🇪🇸Barcelona, Spain
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
Umea Universitet
🇸🇪Umea, Sweden
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Middlesex Hospital
🇬🇧London, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Institut Prive de Cancerologie
🇫🇷Grenoble, France
Ottawa Hospital Regional Cancer Centre - General Campus
🇨🇦Ottawa, Ontario, Canada
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Northeastern Ontario Regional Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Hopital Haut Leveque
🇫🇷Pessac, France
Hopital Rene Dubos
🇫🇷Pontoise, France
Centre Hospitalier Valence
🇫🇷Valence, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Waikato Hospital
🇳🇿Hamilton, New Zealand
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
University Hospital Rebro
ðŸ‡ðŸ‡·Zagreb, Croatia
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands