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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Radiation: radiation therapy; Drug: prednisone; Drug: epirubicin hydrochloride; Drug: vinblastine sulfate; Biological: bleomycin sulfate; Drug: BEACOPP regimen; Drug: ABVD regimen

Detailed Description

OBJECTIVES:

• Compare the late toxicity of 6 courses of epirubicin, bleomycin, vinblastine, and prednisone (EBVP) followed by involved-field radiotherapy (IF-RT) (36 Gy) vs IF-RT (20 Gy), vs no IF-RT (closed to accrual as of 6/2002) in patients with supradiaphragmatic Hodgkin's lymphoma, favorable prognosis, and complete remission (CR) or CR unconfirmed after completion of chemotherapy. (Favorable prognosis group [group 1] closed to accrual as of 4/28/04.)
• Compare 6 courses of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs 4 courses of ABVD vs 4 courses of cyclophosphamide, doxorubicin, vincristine, bleomycin, etoposide, procarbazine, and prednisone (BEACOPP) followed by IF-RT, with respect to overall survival and late treatment-related toxicity, in patients with supradiaphragmatic Hodgkin's lymphoma and unfavorable prognosis. (Unfavorable prognosis group [group 2] closed to accrual as of 9/2002.) (Favorable prognosis group [group 1] closed to accrual as of 4/28/04.)
• Maintain the failure-free survival and relapse-free survival rates that were reached in the previous EORTC studies (H5 to H8), with a reduction in acute and delayed side effects of the treatment, in particular that of severe late radiotherapy and chemotherapy-related toxicity.
• Compare the quality of life, overall survival, treatment quality control, and duration of treatment in patients with favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognoses treated with these regimens.
• Determine the efficacy of conservative therapy comprised of observation until disease progression (DP) and administration of IF-RT at the time of DP in patients with lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma).

OUTLINE: This is a randomized, multicenter study.

Patients with classical Hodgkin's lymphoma are assigned to 1 of 2 randomized groups. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.) Patients with lymphocyte-predominant Hodgkin's lymphoma are assigned to the nonrandomized group.

Randomized groups

• Patients are stratified by prognosis (favorable vs unfavorable). Patients are assigned to 1 of 2 treatment groups based on prognosis. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.)

  • Group 1 (favorable prognosis) (closed to accrual as of 4/28/04): Patients receive epirubicin IV over 5 minutes, bleomycin intramuscularly (IM) (or IV if necessary), and vinblastine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 6 courses. Patients are then assigned to 1 of 3 involved-field radiotherapy (IF-RT) groups based on response to chemotherapy:

    • Group A (complete remission (CR) or CR unconfirmed [CRu]) Patients are randomized to 1 of 3 radiotherapy arms. (Arm III closed to accrual as of 6/2002.)

      • Arm I (36 Gy): Patients undergo IF-RT 5 days a week for 3.5 weeks.
      • Arm II (20 Gy): Patients undergo IF-RT 5 days a week for 2 weeks.
      • Arm III (closed to accrual as of 6/2002): Patients undergo no IF-RT.
    • Group B (partial remission [PR]): Patients undergo IF-RT 5 days a week for 3.5 weeks and boost radiotherapy.
    • Group C (stable disease or disease progression [DP]): Patients receive no IF-RT and are taken off study.

  • Group 2 (unfavorable prognosis) (closed to accrual as of 9/2002): Patients are randomized to 1 of 3 treatment arms.

    • Arm I: Patients receive doxorubicin IV over 5 minutes, bleomycin IM (or IV if necessary), vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses.
    • Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 4 weeks for 4 courses.
    • Arm III: Patients receive cyclophosphamide IV and doxorubicin IV over 5 minutes on day 1, vincristine IV and bleomycin IM (or IV if necessary) on day 8, etoposide IV over a minimum of 30 minutes on days 1-3, oral procarbazine on days 1-7, and oral prednisone on days 1-14. Treatment repeats every 3 weeks for 4 courses.

Patients on all arms who achieve CR or CRu undergo IF-RT 5 days a week for 3 weeks. Patients who achieve PR undergo IF-RT 5 days a week for 3.5 weeks and boost radiotherapy.

• Groups 1 and 2 (group 2 closed to accrual as of 9/2002) (group 1 closed to accrual as of 4/28/04): IF-RT begins within 3-4 weeks after completion of the last course of chemotherapy.

Nonrandomized group

• Patients with completely resected stage I disease undergo observation until DP and undergo IF-RT after documentation of DP. Patients with stage II or incompletely resected stage I disease undergo IF-RT immediately.

Quality of life is assessed before starting study therapy, immediately after completion of study, and then annually for 10 years.

Patients are followed at 2, 4, 6, 9, and 12 months; every 4 months for 1 year; every 6 months for 3 years; and then annually thereafter.

PROJECTED ACCRUAL: A total of 903 patients (group 1) will be accrued for this study within 7.7 years. A total of 723 patients (group 2) will be accrued for this study within 3.8 years. (Group 2 [unfavorable prognosis] closed to accrual as of 9/2002.) (Group 1 [favorable prognosis] closed to accrual as of 4/28/04.)

• Study Type: Interventional
• Enrollment (Actual): 1649
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-free rate	with events defined as lack of CR/CRu at the end of treatment or relapse	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Till withdrawal criteria met
Failure Free Survival	Till withdrawal criteria met
Relapse Free Survival	Till withdrawal criteria met

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: UNICANCER; Lymphoma Study Association
• Investigators: Study Chair: Jose Thomas, MD, University Hospital, Gasthuisberg; Study Chair: H. Eghbali, MD, Institut Bergonie; 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 Léon Bérard

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 1998
• Primary Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: May 2, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimated): January 27, 2003

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Epirubicin; Prednisone; Bleomycin; Vinblastine
• Other Study ID Numbers: EORTC-20982; FRE-FNCLCC-98014 (Other Identifier: FRE-FNCLCC); GELA-H9 (Other Identifier: GELA)