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

Information source: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological); filgrastim (Biological); pegfilgrastim (Biological); 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 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: European Organisation for Research and Treatment of Cancer - EORTC

Official(s) and/or principal investigator(s):
Patrice P. Carde, MD, Study Chair, Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
David C. Linch, Study Chair, Affiliation: Middlesex Hospital
Marine Divine, MD, Study Chair, Affiliation: Centre Hospitalier Universitaire Henri Mondor
Anna Sureda, Study Chair, Affiliation: Hospital de la Santa Cruz i Sant Pau
Ralph M. Meyer, MD, FRCPC, Study Chair, Affiliation: Margaret and Charles Juravinski Cancer Centre
David Ma, MD, Study Chair, Affiliation: St. Vincent’s Hospital.
Devinder Gill, MD, Study Chair, Affiliation: Princess Alexandra Hospital
Bengt Glimelius, MD, Study Chair, Affiliation: Uppsala University Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-free survival

Secondary outcome:

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

Occurrence of secondary malignancies

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.

Eligibility

Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp 2020, Belgium

AZ Sint-Jan, Brugge 8000, Belgium

Centre Hospitalier Universitaire Brugmann, Brussels B 1020, Belgium

Cliniques Universitaires Saint-Luc, Brussels 1200, Belgium

Hopital Universitaire Erasme, Brussels 1070, Belgium

Institut Jules Bordet, Brussels 1000, Belgium

Centre Hospitalier Notre Dame - Reine Fabiola, Charleroi 6000, Belgium

Universitair Ziekenhuis Antwerpen, Edegem B-2650, Belgium

Algemeen Ziekenhuis Sint Lucas, Ghent B-9000, Belgium

Hopital de Jolimont, Haine Saint Paul 7100, Belgium

U.Z. Gasthuisberg, Leuven B-3000, Belgium

Centre Hospitalier Regional de la Citadelle, Liege 4000, Belgium

Clinique Universitaire De Mont-Godinne, Mont-Godinne Yvoir 5530, Belgium

H. Hartziekenhuis - Roeselaere, Roeselare 8800, Belgium

University Hospital Rebro, Zagreb 41000, Croatia

Thomayer's University Hospital, Prague 14000, Czech Republic

Centre Hospitalier d'Annecy, Annecy 74011 Cedex, France

Centre Hospitalier de la Cote Basque, Bayonne 64100, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon 25030, France

Institut Bergonie, Bordeaux 33076, France

Polyclinique Bordeaux Nord Aquitaine, Boucher 33300, France

C.H. Bourg En Bresse, Bourg En Bresse 01012, France

Centre Regional Francois Baclesse, Caen 14076, France

CHU de Caen, Caen 14033, France

Polyclinique Du Parc, Caen 14052, France

Centre Hospitalier Regional de Chambery, Chambery 73011, France

Hopital Antoine Beclere, Clamart 92141, France

Hopital d'Instruction des Armees Percy, Clamart 92140, France

CHR Clermont Ferrand, Hotel Dieu, Clermont-Ferrand 63003, France

Hopital Louis Pasteur, Colmar 68024, France

Centre Hospitalier Sud Francilien - Site Corbeil, Corbeil 91100, France

Centre Hospitalier Universitaire Henri Mondor, Creteil 94010, France

Hopital Du Bocage, Dijon 21034, France

Institut Prive de Cancerologie, Grenoble 38100, France

Hopital Andre Mignot, Le Chesnay 78157, France

Centre Hospitalier Regional et Universitaire de Lille, Lille 59037, France

Hopital Saint Antoine Lille, Lille 59000, France

Centre Hospital Regional Universitaire de Limoges, Limoges 87042, France

Centre Leon Berard, Lyon 69373, France

Hopital Edouard Herriot - Lyon, Lyon 69437, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille 13273, France

Centre Hospitalier de Meaux, Meaux 77104, France

Centre Hospitalier Marc Jacquet, Melun 77011, France

Hopital Notre-Dame de Bon Secours, Metz 55038, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier 34298, France

Centre Hospitalier de Mulhouse, Mulhouse 68051, France

Centre Antoine Lacassagne, Nice 06189, France

Hopital de l'Archet CHU de Nice, Nice F-06202, France

CHU Pitie-Salpetriere, Paris 75651, France

Hopital Cochin, Paris 75674, France

Hopital Necker, Paris 75743, France

Hopital Saint Antoine, Paris 75571, France

Hopital Saint-Louis, Paris 75475, France

Hotel Dieu de Paris, Paris 75181, France

Institut Curie Hopital, Paris 75248, France

Hopital Haut Leveque, Pessac 33604, France

Centre Hospitalier Lyon Sud, Pierre Benite 69495, France

Hopital Rene Dubos, Pontoise 95300, France

Institut Jean Godinot, Reims 51056, France

Hopital Sud, Rennes 35056, France

Centre Henri Becquerel, Rouen 76038, France

Centre Rene Huguenin, Saint Cloud 92211, France

CHU Sainte-Etienne - Hopital Bellevue, Saint Etienne 42055, France

Hopital de Saint Germain-en-Laye, Saint Germain-en-Laye 78104, France

Hopital Universitaire Hautepierre, Strasbourg 67098, France

Hopital Foch, Suresnes 92151, France

Centre Hospitalier Valence, Valence 26000, France

Centre Hospitalier de Valenciennes, Valenciennes 59300, France

CHU de Nancy - Hopitaux de Brabois, Vandoeuvre-Les-Nancy 54511, France

Hopital Paul Brousse, Villejuif 94804, France

Institut Gustave Roussy, Villejuif F-94805, France

National Institute of Oncology, Budapest 1122, Hungary

HagaZiekenhuis - Locatie Leyenburg, 's-Gravenhage 2545 CH, Netherlands

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch 5211 NL, Netherlands

Meander Medisch Centrum, Amersfoort 3816 CP, Netherlands

Academisch Medisch Centrum at University of Amsterdam, Amsterdam 1105 AZ, Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam 1066 CX, Netherlands

Onze Lieve Vrouwe Gasthuis, Amsterdam 1091 HA, Netherlands

Reinier de Graaf Group - Delft, Delft NL 2600 GA, Netherlands

Medisch Spectrum Twente, Enschede 7500 KA, Netherlands

University Medical Center Groningen, Groningen 9713 EZ, Netherlands

Atrium Medical Centre - Heerlen, Heerlen 6419 PC, Netherlands

Leiden University Medical Center, Leiden 2300 CA, Netherlands

Academisch Ziekenhuis Maastricht, Maastricht 6202 AZ, Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen NL-6500 HB, Netherlands

Saint Laurentius Ziekenhuis, Roermond 6043 CV, Netherlands

Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam 3008 AE, Netherlands

University Medical Center Utrecht, Utrecht 3584 CX, Netherlands

Auckland City Hospital, Auckland 1, New Zealand

Waikato Hospital, Hamilton 2020, New Zealand

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw, Warsaw 02-781, Poland

Hospital Clinic de Barcelona, Barcelona 08036, Spain

Hospital de la Santa Cruz i Sant Pau, Barcelona 08025, Spain

Hospital Universitari Germans Trias i Pujol, Barcelona 08916, Spain

Sahlgrenska University Hospital, Gothenburg (Goteborg) S-413 45, Sweden

University Hospital of Linkoping, Linkoping S-581 85, Sweden

Lund University Hospital, Lund S-22185, Sweden

Karolinska University Hospital - Huddinge, Stockholm S-141 86, Sweden

Umea Universitet, Umea S-901 85, Sweden

Uppsala University Hospital, Uppsala S-75185, Sweden

Tom Baker Cancer Centre - Calgary, Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute at University of Alberta, Edmonton, Alberta T6G 1Z2, Canada

Canberra Hospital, Woden, Australian Capital Territory 2606, Australia

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England B15 2TH, United Kingdom

Raigmore Hospital, Birmingham, England B15 2TH, United Kingdom

Kent and Canterbury Hospital, Canterbury, England CT2 7NR, United Kingdom

Hull Royal Infirmary, Hull, England HU3 2KZ, United Kingdom

Kettering General Hosptial, Kettering, Northants, England NNI6 8UZ, United Kingdom

Leicester Royal Infirmary, Leicester, England LE1 5WW, United Kingdom

Middlesex Hospital, London, England WC1E 6HX, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom

Staffordshire General Hospital, Stafford, England ST16 3SA, United Kingdom

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Centre Hospitalier De Dunkerque - CHD, Winnipeg, Manitoba R3E 0V9, Canada

Moncton Hospital, Moncton, New Brunswick E1C 6ZB, Canada

Nepean Cancer Care Centre at Nepean Hospital, Kingswood, New South Wales 2747, Australia

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales 2145, Australia

Doctor H. Bliss Murphy Cancer Centre, St. Johns, Newfoundland and Labrador A1B 3V6, Canada

Nova Scotia Cancer Centre, Halifax, Nova Scotia B3H 1V7, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario K7L 5P9, Canada

London Regional Cancer Program at London Health Sciences Centre, London, Ontario N6A 4L6, Canada

Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario K1H 8L6, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario P3E 5J1, Canada

Edmond Odette Cancer Centre at Sunnybrook, Toronto, Ontario M4N 3M5, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Windsor Regional Cancer Centre at Windsor Regional Hospital, Windsor, Ontario N8W 2X3, Canada

Hopital Charles Lemoyne, Greenfield Park, Quebec J4V 2H1, Canada

CHUM - Hotel Dieu Hospital, Montreal, Quebec H2L-4M1, Canada

Hopital Notre-Dame du CHUM, Montreal, Quebec H2L 4M1, Canada

Maisonneuve-Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada

McGill Cancer Centre at McGill University, Montreal, Quebec H2W 1S6, Canada

Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec G1R 2J6, Canada

Hopital du Saint-Sacrement - Quebec, Quebec City, Quebec G1S 4L8, Canada

Princess Alexandra Hospital, Brisbane, Queensland 4102, Australia

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada

Peter MacCallum Cancer Centre, East Melbourne, Victoria 3002, Australia

St. Vincent's Hospital - Melbourne, Fitzroy, Victoria 3065, Australia

Royal Perth Hospital, Perth, Western Australia 6000, Australia

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2002
Last updated: June 13, 2014

Page last updated: August 23, 2015

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