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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00005584
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 27, 2017
Sponsor:
Collaborators:
Lymphoma Study Association
UNICANCER
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: bleomycin sulfate Drug: ABVD regimen Drug: BEACOPP regimen Drug: epirubicin hydrochloride Drug: prednisone Drug: vinblastine sulfate Radiation: radiation therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1649 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups
Study Start Date : October 1998
Actual Primary Completion Date : May 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Relapse-free rate [ Time Frame: 5 years ]
    with events defined as lack of CR/CRu at the end of treatment or relapse


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Till withdrawal criteria met ]
  2. Failure Free Survival [ Time Frame: Till withdrawal criteria met ]
  3. Relapse Free Survival [ Time Frame: Till withdrawal criteria met ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005584


  Hide Study Locations
Locations
Belgium
Sint Augustinus Ziekenhuis
Antwerpen, Belgium, 2610
A.Z. St. Jan
Brugge, Belgium, 8000
C.H.U. Saint-Pierre
Brussels, Belgium, 1000
Institut Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium, B 1020
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, Belgium, 5530
Clinique Saint-Pierre
Ottignies, Belgium, B-1340
France
Centre Hospitalier Annemasse Bonneville
Ambilly, France, 74100
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
Centre Hospital General Robert Ballanger
Aulnay Sous Bois, France, 93602
Hopital Duffaut
Avignon, France, 84902
Centre Hospitalier de la Cote Basque
Bayonne, France, 64109
CHR de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital de Beziers
Beziers, France, 34500
Hopital Saint Andre
Bordeaux, France, 33075
Institut Bergonie
Bordeaux, France, 33076
C.H. Bourg En Bresse
Bourg En Bresse, France, 01012
CMC Bligny
Briis Sous Forges, France, 91640
CHU de Caen
Caen, France, 14033
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Hospitalier Regional de Chambery
Chambery, France, 73011
Hopital Fontenoy
Chartres, France, 28018
Centre d'Oncologie et de Radiotherapie de Chaumont le Bois
Chaumont, France, 52000
Hopital d'Instruction des Armees Percy
Clamart, France, 92140
Hopital Antoine Beclere
Clamart, France, 92141
Hopital Beaujon
Clichy, France, 92110
Hopital Louis Pasteur
Colmar, France, 68024
Centre Hospitalier Compiegne
Compiegne, France, 60321
Centre Hospitalier Sud Francilien - Site Corbeil
Corbeil, France, 91100
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Hopital Du Bocage
Dijon, France, 21034
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, France, 21079
Institut Prive de Cancerologie
Grenoble, France, 38100
Centre Hospitalier
Juvisy sur Orge, France, 91260
Hopital Andre Mignot
Le Chesnay, France, 78157
C.H.G. Du Havre - Hopital J. Monod
Le Havre, France, 76083
Centre Hospitalier Universitaire de Bicetre
Le Kremlin Bicetre, France, 94275
Clinique Victor Hugo
Le Mans, France, F-72000
Centre Hospitalier Lens
Lens, France, Cedex 62307
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospitalier Regional et Universitaire de Lille
Lille, France, 59037
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Centre Hospitalier General
Lons le Saunier, France, 39000
Clinique Saint Jean
Lyon, France, 69008
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot
Lyon, France, 69437
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Hospitalier de Meaux
Meaux, France, 77104
Hopital Notre-Dame de Bon Secours
Metz, France, 55038
Intercommunal Hospital
Montfermeil, France, 93370
Clinique Gui de Chauliac
Montpellier, France, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Hopital Pasteur
Nice, France, 06002
Centre Antoine Lacassagne
Nice, France, 06189
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nimes, France, 30000
Hopital Saint Antoine
Paris, France, 75012
Hopital de la Croix Rouge Francaise des Peupliers
Paris, France, 75013
Hotel Dieu de Paris
Paris, France, 75181
Institut Curie - Section Medicale
Paris, France, 75248
Hopital Lariboisiere
Paris, France, 75475
Hopital Saint-Louis
Paris, France, 75475
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Cochin
Paris, France, 75674
Hopital Necker
Paris, France, 75743
C.H.G. De Pau
Pau, France, 64046 Universite Cedex
Hopital Haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69310
Centre Hospitalier Intercommunal de Poissy
Poissy, France, 78498
Hopital Rene Dubos
Pontoise, France, 95300
Polyclinique De Courlancy
Reims, France, F-51100
CHG Roanne
Roanne, France, F-42300
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92211
C.H.U. Saint Etienne Hospital Nord
Saint Etienne, France, 42055
Hopital de Saint Germain-en-Laye
Saint Germain-en-Laye, France, 78104
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Centre Hospitalier Regional de Purpan
Toulouse, France, 31059
Centre Hospitalier Valence
Valence, France, 26000
Centre Hospitalier de Valenciennes
Valenciennes, France, 59300
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
CHU de Nancy - Hopitaux de Brabois
Vandoeuvre-Les-Nancy, France, 54511
Hopital Paul Brousse
Villejuif, France, 94804
Institut Gustave Roussy
Villejuif, France, F-94805
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospedale Sta. Maria Delle Croci
Ravenna, Italy, 48100
Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Turin
Turin, Italy, 10123
Netherlands
Leyenburg Ziekenhuis
's-Gravenhage, Netherlands, 2545 CH
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, Netherlands, 5211 NL
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Meander Medisch Centrum
Amersfoort, Netherlands, 3816 CP
Comprehensive Cancer Center Amsterdam
Amsterdam, Netherlands, 1006 CX
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Streekziekenhuizen Gooi-Noord
Blaricum, Netherlands, 1261 AN
Amphia Ziekenhuis - locatie Molengracht
Breda, Netherlands, 4818 CK
Atrium Medisch Centrum - Brunssum
Brunssum, Netherlands, 6442 BE
Reinier de Graaf Group
Delft, Netherlands, NL 2600 GA
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Atrium Medical Centre
Heerlen, Netherlands, 6419 PC
Radiotherapeutisch Instituut
Leeuwarden, Netherlands, 8934 AD
Diaconessenhuis Leiden
Leiden, Netherlands, 2300 RD
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
Maasland Hospital
Sittard, Netherlands, 6131 BK
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
Portugal
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, Portugal, 4200
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Slovenia
Institute of Oncology, Ljubljana
Ljubljana, Slovenia, Sl-1000
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Lymphoma Study Association
UNICANCER
Investigators
Study Chair: 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

Publications of Results:
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.
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.
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.
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.
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.
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.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00005584     History of Changes
Other Study ID Numbers: EORTC-20982
FRE-FNCLCC-98014 ( Other Identifier: FRE-FNCLCC )
GELA-H9 ( Other Identifier: GELA )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Epirubicin
Bleomycin
Vinblastine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators