Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

NCT00005584 | Active Not Recruiting Phase 3

• 3 other identifiers: EORTC-20982FRE-FNCLCC-98014GELA-H9
• Study Type: interventional
• Target: 1,649
• Locations: 9 countries
• Sites: 120

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Relapse-free rate

  with events defined as lack of CR/CRu at the end of treatment or relapse

  5 years

Secondary Outcomes (3)

• Overall Survival

  Till withdrawal criteria met

• Failure Free Survival

  Till withdrawal criteria met

• Relapse Free Survival

  Till withdrawal criteria met

Interventions

bleomycin sulfate BIOLOGICAL

ABVD regimen DRUG

BEACOPP regimen DRUG

epirubicin hydrochloride DRUG

prednisone DRUG

vinblastine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Randomized groups: Histologically proven previously untreated stage I or II supradiaphragmatic Hodgkin's lymphoma * No prior staging laparotomy * Favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognosis * Nonrandomized group: Histologically proven lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma) * Stage I with complete or incomplete resection OR * Stage II PATIENT CHARACTERISTICS: Age: * 15 to 70 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No severe cardiac disease that would interfere with normal life expectancy or study treatment Pulmonary: * No severe pulmonary disease that would interfere with normal life expectancy or study treatment Other: * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No severe neurologic or metabolic disease that would interfere with normal life expectancy or study treatment * No psychologic, familial, socioeconomic, or geographic circumstances that would preclude proper staging or compliance * HIV negative * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for this malignancy Chemotherapy * No prior chemotherapy for this malignancy Endocrine therapy * No prior endocrine therapy for this malignancy Radiotherapy * No prior radiotherapy for this malignancy Surgery * No prior surgery for this malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Lymphoma Study Association: collaborator
• UNICANCER: collaborator

Study Sites (121)

Sint Augustinus Ziekenhuis

Antwerp, 2610, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

C.H.U. Saint-Pierre

Brussels, 1000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels, B 1020, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

Clinique Saint-Pierre

Ottignies, B-1340, Belgium

Location

Centre Hospitalier Annemasse Bonneville

Ambilly, 74100, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Centre Hospital General Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64109, France

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital de Beziers

Béziers, 34500, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

CMC Bligny

Briis-sous-Forges, 91640, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Regional de Chambery

Chambéry, 73011, France

Location

Hopital Fontenoy

Chartres, 28018, France

Location

Centre d'Oncologie et de Radiotherapie de Chaumont le Bois

Chaumont, 52000, France

Location

Hopital d'Instruction des Armees Percy

Clamart, 92140, France

Location

Hopital Antoine Beclere

Clamart, 92141, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Compiegne

Compiègne, 60321, France

Location

Centre Hospitalier Sud Francilien - Site Corbeil

Corbeil, 91100, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

Institut Prive de Cancerologie

Grenoble, 38100, France

Location

Centre Hospitalier

Juvisy-sur-Orge, 91260, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

C.H.G. Du Havre - Hopital J. Monod

Le Havre, 76083, France

Location

Centre Hospitalier Universitaire de Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Centre Hospitalier Lens

Lens, Cedex 62307, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Hospitalier General

Lons-le-Saunier, 39000, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 55038, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

Clinique Gui de Chauliac

Montpellier, 34295, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Hopital Pasteur

Nice, 06002, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

Nîmes, 30000, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital de la Croix Rouge Francaise des Peupliers

Paris, 75013, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Hopital Lariboisiere

Paris, 75475, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Necker

Paris, 75743, France

Location

C.H.G. De Pau

Pau, 64046 Universite Cedex, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Intercommunal de Poissy

Poissy, 78498, France

Location

Hopital Rene Dubos

Pontoise, 95300, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

CHG Roanne

Roanne, F-42300, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

C.H.U. Saint Etienne Hospital Nord

Saint-Etienne, 42055, France

Location

Hopital de Saint Germain-en-Laye

Saint-Germain-en-Laye, 78104, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31059, France

Location

Centre Hospitalier Valence

Valence, 26000, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

CHU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Ospedale Sta. Maria Delle Croci

Ravenna, 48100, Italy

Location

Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Turin

Turin, 10123, Italy

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5211 NL, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Meander Medisch Centrum

Amersfoort, 3816 CP, Netherlands

Location

Comprehensive Cancer Center Amsterdam

Amsterdam, 1006 CX, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Streekziekenhuizen Gooi-Noord

Blaricum, 1261 AN, Netherlands

Location

Amphia Ziekenhuis - locatie Molengracht

Breda, 4818 CK, Netherlands

Location

Atrium Medisch Centrum - Brunssum

Brunssum, 6442 BE, Netherlands

Location

Reinier de Graaf Group

Delft, NL 2600 GA, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

Atrium Medical Centre

Heerlen, 6419 PC, Netherlands

Location

Radiotherapeutisch Instituut

Leeuwarden, 8934 AD, Netherlands

Location

Diaconessenhuis Leiden

Leiden, 2300 RD, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Maasland Hospital

Sittard, 6131 BK, Netherlands

Location

Leyenburg Ziekenhuis

The Hague, 2545 CH, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Instituto Portugues de Oncologia Centro do Porto, SA

Porto, 4200, Portugal

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (10)

• van der Kaaij MA, Heutte N, van Echten-Arends J, Raemaekers JM, Carde P, Noordijk EM, Ferme C, Thomas J, Eghbali H, Brice P, Bonmati C, Henry-Amar M, Kluin-Nelemans HC. Sperm quality before treatment in patients with early stage Hodgkin's lymphoma enrolled in EORTC-GELA Lymphoma Group trials. Haematologica. 2009 Dec;94(12):1691-7. doi: 10.3324/haematol.2009.009696. Epub 2009 Oct 22.

  PMID: 19850901 BACKGROUND

• van der Kaaij MA, Heutte N, Le Stang N, Raemaekers JM, Simons AH, Carde P, Noordijk EM, Ferme C, Thomas J, Eghbali H, Kluin-Nelemans HC, Henry-Amar M; European Organisation for Research and Treatment of Cancer: EORTC Lymphoma Group; Groupe d'Etude des Lymphomes de l'Adulte. Gonadal function in males after chemotherapy for early-stage Hodgkin's lymphoma treated in four subsequent trials by the European Organisation for Research and Treatment of Cancer: EORTC Lymphoma Group and the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2007 Jul 1;25(19):2825-32. doi: 10.1200/JCO.2006.10.2020. Epub 2007 May 21.

  PMID: 17515571 BACKGROUND

• Eghbali H, Brice P, Creemers GY, et al.: Comparison of three radiation dose levels after EBVP regimen in favorable supradiaphragmatic clinical stages (CS) I-II Hodgkin's lymphoma (HL): preliminary results of the EORTC-GELA H9-F trial. [Abstract] Blood 106 (11): A-814, 2005.

  RESULT

• Ferme C, Diviné M, Vranovsky A, et al.: Four ABVD and involved-field radiotherapy in unfavorable supradiaphragmatic clinical stages (CS) I-II Hodgkin's lymphoma (HL): preliminary results of the EORTC-GELA H9-U trial. [Abstract] Blood 106 (11): A-813, 2005.

  RESULT

• Girinsky T, Gargi T, Carrie C, et al.: Quality assurance program in the EORTC-GELA H9 randomized study results on 282 patients. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A77, S47, 2005.

  RESULT

• Noordijk EM, Thomas J, Fermé C, et al.: First results of the EORTC-GELA H9 randomized trials: the H9-F trial (comparing 3 radiation dose levels) and H9-U trial (comparing 3 chemotherapy schemes) in patients with favorable or unfavorable early stage Hodgkin's lymphoma (HL) . [Abstract] J Clin Oncol 23 (Suppl 16): A-6505, 561s, 2005.

  RESULT

• Thomas J, Ferme C, Noordijk EM, et al.: Six cycles of EBVP followed by 36 Gy involved-field irradiation vs. no irradiation in favourable supradiaphragmatic clinical stages I-II Hodgkin's lymphoma: the EORTC-GELA strategy in 771 patients (H9-F trial-20982). [Abstract] Eur J Haematol 75 (Suppl 65): A-E11a, 40, 2004.

  RESULT

• Thomas J, Ferme C, Noordijk EM, et al.: Six cycles of ABVD + IF-RT vs. four cycles of ABVD + IF-RT vs. four cycles of BEACOPP + IF-RT in unfavourable supradiaphragmatic clinical stages I-II Hodgkin's lymphoma: the EORTC-GELA H9-U randomized clinical trial (20982) in 808 patients. [Abstract] Eur J Haematol 73 (Supp 65): A-E12, 40, 2004.

  RESULT

• Thomas J, Ferme C, Noordijk EM, Morschhauser F, Girinsky T, Gaillard I, Lugtenburg PJ, Andre M, Lybeert MLM, Stamatoullas A, Beijert M, Helias P, Eghbali H, Gabarre J, van der Maazen RWM, Jaubert J, Bouabdallah K, Boulat O, Roesink JM, Christian B, Ong F, Bordessoule D, Tertian G, Gonzalez H, Vranovsky A, Quittet P, Tirelli U, de Jong D, Audouin J, Aleman BMP, Henry-Amar M. Comparison of 36 Gy, 20 Gy, or No Radiation Therapy After 6 Cycles of EBVP Chemotherapy and Complete Remission in Early-Stage Hodgkin Lymphoma Without Risk Factors: Results of the EORT-GELA H9-F Intergroup Randomized Trial. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1133-1145. doi: 10.1016/j.ijrobp.2017.10.015. Epub 2017 Oct 27.

  PMID: 29229324 DERIVED

• Ferme C, Thomas J, Brice P, Casasnovas O, Vranovsky A, Bologna S, Lugtenburg PJ, Bouabdallah R, Carde P, Sebban C, Eghbali H, Salles G, van Imhoff GW, Thyss A, Noordijk EM, Reman O, Lybeert MLM, Janvier M, Spina M, Audhuy B, Raemaekers JMM, Delarue R, Anglaret B, de Weerdt O, Marjanovic Z, Tersteeg RJHA, de Jong D, Briere J, Henry-Amar M; European Organisation for Research and Treatment of Cancer Lymphoma Group, and; Groupe d'Etude des Lymphomes de l'Adulte. ABVD or BEACOPPbaseline along with involved-field radiotherapy in early-stage Hodgkin Lymphoma with risk factors: Results of the European Organisation for Research and Treatment of Cancer (EORTC)-Groupe d'Etude des Lymphomes de l'Adulte (GELA) H9-U intergroup randomised trial. Eur J Cancer. 2017 Aug;81:45-55. doi: 10.1016/j.ejca.2017.05.005. Epub 2017 Jun 8.

  PMID: 28601705 DERIVED

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; ABVD protocol; Epirubicin; Prednisone; Vinblastine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Jose Thomas, MD

  University Hospital, Gasthuisberg

  STUDY CHAIR

• H. Eghbali, MD

  Institut Bergonié

  STUDY CHAIR

• E.M. Noordijk, MD

  Leiden University Medical Center

  STUDY CHAIR

• Christophe Ferme

  Centre Medical de Bligny

  STUDY CHAIR

• Christian Gisselbrecht, MD

  Hopital Saint-Louis

  STUDY CHAIR

• Thierry O. Philip, MD

  Centre Leon Berard

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 1998
• Primary Completion: May 1, 2004
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

SL (1); CH (2); BE (10); NL (24); ES (1); FR (77); IT (3); PT (1); PL (1)