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AzTrials

LymphomaPhase 3NCT00005584

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

A Phase 3 study testing bleomycin sulfate, ABVD regimen and BEACOPP regimen in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 121 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
bleomycin sulfate, ABVD regimen and BEACOPP regimen
Type of treatment
Surgery or procedure
How many people
1,649 participants
Where
121 sitesin 10 countries
Study dates
Oct 1998to May 2004
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

121 sites in 10 countries.

121 sites in 10 countries

France77 sites

  • Centre Hospitalier Annemasse Bonneville

    Ambilly, 74100

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Centre Hospital General Robert Ballanger

    Aulnay-sous-Bois, 93602

  • Hopital Duffaut

    Avignon, 84902

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64109

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital de Beziers

    Béziers, 34500

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • C.H. Bourg En Bresse

    Bourg-en-Bresse, 01012

  • CMC Bligny

    Briis-sous-Forges, 91640

  • CHU de Caen

    Caen, 14033

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Regional de Chambery

    Chambéry, 73011

  • Hopital Fontenoy

    Chartres, 28018

  • Centre d'Oncologie et de Radiotherapie de Chaumont le Bois

    Chaumont, 52000

  • Hopital d'Instruction des Armees Percy

    Clamart, 92140

  • Hopital Antoine Beclere

    Clamart, 92141

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier Compiegne

    Compiègne, 60321

  • Centre Hospitalier Sud Francilien - Site Corbeil

    Corbeil, 91100

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Hopital Du Bocage

    Dijon, 21034

  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

    Dijon, 21079

  • Institut Prive de Cancerologie

    Grenoble, 38100

  • Centre Hospitalier

    Juvisy-sur-Orge, 91260

  • Hopital Andre Mignot

    Le Chesnay, 78157

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

    Le Havre, 76083

  • Centre Hospitalier Universitaire de Bicetre

    Le Kremlin-Bicêtre, 94275

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Centre Hospitalier Lens

    Lens, Cedex 62307

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Hospitalier General

    Lons-le-Saunier, 39000

  • Clinique Saint Jean

    Lyon, 69008

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot

    Lyon, 69437

  • Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • Hopital Notre-Dame de Bon Secours

    Metz, 55038

  • Intercommunal Hospital

    Montfermeil, 93370

  • Clinique Gui de Chauliac

    Montpellier, 34295

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

    Montpellier, 34298

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Hopital Pasteur

    Nice, 06002

  • Centre Antoine Lacassagne

    Nice, 06189

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

    Nîmes, 30000

  • Hopital Saint Antoine

    Paris, 75012

  • Hopital de la Croix Rouge Francaise des Peupliers

    Paris, 75013

  • Hotel Dieu de Paris

    Paris, 75181

  • Institut Curie - Section Medicale

    Paris, 75248

  • Hopital Lariboisiere

    Paris, 75475

  • Hopital Saint-Louis

    Paris, 75475

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Cochin

    Paris, 75674

  • Hopital Necker

    Paris, 75743

  • C.H.G. De Pau

    Pau, 64046 Universite Cedex

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Intercommunal de Poissy

    Poissy, 78498

  • Hopital Rene Dubos

    Pontoise, 95300

  • Polyclinique De Courlancy

    Reims, F-51100

  • CHG Roanne

    Roanne, F-42300

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • C.H.U. Saint Etienne Hospital Nord

    Saint-Etienne, 42055

  • Hopital de Saint Germain-en-Laye

    Saint-Germain-en-Laye, 78104

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Centre Hospitalier Regional de Purpan

    Toulouse, 31059

  • Centre Hospitalier Valence

    Valence, 26000

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59300

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • CHU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hopital Paul Brousse

    Villejuif, 94804

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Netherlands24 sites

  • Groot Ziekengasthuis 's-Hertogenbosch

    's-Hertogenbosch, 5211 NL

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Meander Medisch Centrum

    Amersfoort, 3816 CP

  • Comprehensive Cancer Center Amsterdam

    Amsterdam, 1006 CX

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Streekziekenhuizen Gooi-Noord

    Blaricum, 1261 AN

  • Amphia Ziekenhuis - locatie Molengracht

    Breda, 4818 CK

  • Atrium Medisch Centrum - Brunssum

    Brunssum, 6442 BE

  • Reinier de Graaf Group

    Delft, NL 2600 GA

  • Catharina Ziekenhuis

    Eindhoven, 5602 ZA

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

  • Atrium Medical Centre

    Heerlen, 6419 PC

  • Radiotherapeutisch Instituut

    Leeuwarden, 8934 AD

  • Diaconessenhuis Leiden

    Leiden, 2300 RD

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • Maasland Hospital

    Sittard, 6131 BK

  • Leyenburg Ziekenhuis

    The Hague, 2545 CH

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Belgium10 sites

  • Sint Augustinus Ziekenhuis

    Antwerp, 2610

  • A.Z. St. Jan

    Bruges, 8000

  • C.H.U. Saint-Pierre

    Brussels, 1000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Centre Hospitalier Universitaire Brugmann

    Brussels, B 1020

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

  • Clinique Saint-Pierre

    Ottignies, B-1340

Other trials in Belgium

Italy3 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospedale Sta. Maria Delle Croci

    Ravenna, 48100

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

    Turin, 10123

Other trials in Italy

Switzerland2 sites

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Portugal1 site

  • Instituto Portugues de Oncologia Centro do Porto, SA

    Porto, 4200

Other trials in Portugal

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Slovenia1 site

  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

Spain1 site

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

About this study

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

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.

Read the 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.)

Conditions
Lymphoma
Being tested
bleomycin sulfate, ABVD regimen, BEACOPP regimen, epirubicin hydrochloride, prednisone
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, adult lymphocyte predominant Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bleomycin sulfateBiological

  • ABVD regimenDrug

  • BEACOPP regimenDrug

  • epirubicin hydrochlorideDrug

  • prednisoneDrug

  • vinblastine sulfateDrug

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free rate

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

    Measured: 5 years

Secondary outcomes (3)

  1. Overall Survival

    Measured: Till withdrawal criteria met

  2. Failure Free Survival

    Measured: Till withdrawal criteria met

  3. Relapse Free Survival

    Measured: Till withdrawal criteria met

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 1998
  3. Primary completionMay 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
1,649 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005584
Sponsor's protocol ID
EORTC-20982
Other IDs
FRE-FNCLCC-98014, GELA-H9
Status last verified
Aug 2025
First submitted
2 May 2000
Last updated
5 Aug 2025
Results posted
No

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.

    PubMed 19850901

  • 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.

    PubMed 17515571

  • 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.

  • Martinez Alcala R, Visser L, Fortpied C, Ferme C, Henry-Amar M, Aleman B, Arens A, Juul S, Hayat A, Hude Dragicevic I, Hutchings M, Meijnders P, Mutsaers P, Paszkiewicz-Kozik E, Rossetti S, Sureda A, Syrykh C, Tonino S, Plattel W, Diepstra A. Immunohistochemistry for c-MET, HLA class II, and CD68 does not show prognostic value in early-stage classic Hodgkin lymphoma patients in the EORTC-GELA H9 intergroup randomised trial. PLoS One. 2026 Oct 8;21(10):e0360080. doi: 10.1371/journal.pone.0360080. eCollection 2026.

    PubMed 42848781

  • 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.

    PubMed 29229324

  • 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.

    PubMed 28601705

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, ABVD regimen and BEACOPP regimen in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 121 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in France, Netherlands, Belgium, Italy, Switzerland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005584, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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