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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-98014 | Other Identifier | FRE-FNCLCC | |
| GELA-H9 | Other Identifier | GELA |
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| Name | Class |
|---|---|
| Lymphoma Study Association | OTHER |
| UNICANCER | OTHER |
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.
OBJECTIVES:
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.)
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.
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.
Nonrandomized group
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.)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | |||
| ABVD regimen | Drug | |||
| BEACOPP regimen | Drug | |||
| epirubicin hydrochloride | Drug | |||
| prednisone | Drug | |||
| vinblastine sulfate | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free rate | with events defined as lack of CR/CRu at the end of treatment or relapse | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Till withdrawal criteria met | |
| Failure Free Survival | Till withdrawal criteria met | |
| Relapse Free Survival |
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DISEASE CHARACTERISTICS:
Randomized groups: Histologically proven previously untreated stage I or II supradiaphragmatic Hodgkin's lymphoma
Nonrandomized group: Histologically proven lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Augustinus Ziekenhuis | Antwerp | 2610 | Belgium | |||
| A.Z. St. Jan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19850901 | Background | 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. | |
| 17515571 |
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| Till withdrawal criteria met |
| Bruges |
| 8000 |
| Belgium |
| C.H.U. Saint-Pierre | Brussels | 1000 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Centre Hospitalier Universitaire Brugmann | Brussels | B 1020 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Clinique Universitaire De Mont-Godinne | Mont-Godinne Yvoir | 5530 | Belgium |
| Clinique Saint-Pierre | Ottignies | B-1340 | Belgium |
| Centre Hospitalier Annemasse Bonneville | Ambilly | 74100 | France |
| Centre Hospitalier d'Annecy | Annecy | 74011 Cedex | France |
| Centre Hospital General Robert Ballanger | Aulnay-sous-Bois | 93602 | France |
| Hopital Duffaut | Avignon | 84902 | France |
| Centre Hospitalier de la Cote Basque | Bayonne | 64109 | France |
| CHR de Besancon - Hopital Jean Minjoz | Besançon | 25030 | France |
| Hopital de Beziers | Béziers | 34500 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| C.H. Bourg En Bresse | Bourg-en-Bresse | 01012 | France |
| CMC Bligny | Briis-sous-Forges | 91640 | France |
| CHU de Caen | Caen | 14033 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Hospitalier Regional de Chambery | Chambéry | 73011 | France |
| Hopital Fontenoy | Chartres | 28018 | France |
| Centre d'Oncologie et de Radiotherapie de Chaumont le Bois | Chaumont | 52000 | France |
| Hopital d'Instruction des Armees Percy | Clamart | 92140 | France |
| Hopital Antoine Beclere | Clamart | 92141 | France |
| Hopital Beaujon | Clichy | 92110 | France |
| Hopital Louis Pasteur | Colmar | 68024 | France |
| Centre Hospitalier Compiegne | Compiègne | 60321 | France |
| Centre Hospitalier Sud Francilien - Site Corbeil | Corbeil | 91100 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94010 | France |
| Hopital Du Bocage | Dijon | 21034 | France |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | Dijon | 21079 | France |
| Institut Prive de Cancerologie | Grenoble | 38100 | France |
| Centre Hospitalier | Juvisy-sur-Orge | 91260 | France |
| Hopital Andre Mignot | Le Chesnay | 78157 | France |
| C.H.G. Du Havre - Hopital J. Monod | Le Havre | 76083 | France |
| Centre Hospitalier Universitaire de Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| Clinique Victor Hugo | Le Mans | F-72000 | France |
| Centre Hospitalier Lens | Lens | Cedex 62307 | France |
| Centre Hospital Universitaire Hop Huriez | Lille | 59037 | France |
| Centre Hospitalier Regional et Universitaire de Lille | Lille | 59037 | France |
| Centre Hospital Regional Universitaire de Limoges | Limoges | 87042 | France |
| Centre Hospitalier General | Lons-le-Saunier | 39000 | France |
| Clinique Saint Jean | Lyon | 69008 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| Centre Hospitalier de Meaux | Meaux | 77104 | France |
| Hopital Notre-Dame de Bon Secours | Metz | 55038 | France |
| Intercommunal Hospital | Montfermeil | 93370 | France |
| Clinique Gui de Chauliac | Montpellier | 34295 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Hospitalier de Mulhouse | Mulhouse | 68051 | France |
| Hopital Pasteur | Nice | 06002 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau | Nîmes | 30000 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Hopital de la Croix Rouge Francaise des Peupliers | Paris | 75013 | France |
| Hotel Dieu de Paris | Paris | 75181 | France |
| Institut Curie - Section Medicale | Paris | 75248 | France |
| Hopital Lariboisiere | Paris | 75475 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| CHU Pitie-Salpetriere | Paris | 75651 | France |
| Hopital Cochin | Paris | 75674 | France |
| Hopital Necker | Paris | 75743 | France |
| C.H.G. De Pau | Pau | 64046 Universite Cedex | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Centre Hospitalier Intercommunal de Poissy | Poissy | 78498 | France |
| Hopital Rene Dubos | Pontoise | 95300 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| CHG Roanne | Roanne | F-42300 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| C.H.U. Saint Etienne Hospital Nord | Saint-Etienne | 42055 | France |
| Hopital de Saint Germain-en-Laye | Saint-Germain-en-Laye | 78104 | France |
| Centre Medico-Chirurgical Foch | Suresnes | 92151 | France |
| Centre Hospitalier Regional de Purpan | Toulouse | 31059 | France |
| Centre Hospitalier Valence | Valence | 26000 | France |
| Centre Hospitalier de Valenciennes | Valenciennes | 59300 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| CHU de Nancy - Hopitaux de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Hopital Paul Brousse | Villejuif | 94804 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| Centro di Riferimento Oncologico - Aviano | Aviano | 33081 | Italy |
| Ospedale Sta. Maria Delle Croci | Ravenna | 48100 | Italy |
| Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Turin | Turin | 10123 | Italy |
| Groot Ziekengasthuis 's-Hertogenbosch | 's-Hertogenbosch | 5211 NL | Netherlands |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Meander Medisch Centrum | Amersfoort | 3816 CP | Netherlands |
| Comprehensive Cancer Center Amsterdam | Amsterdam | 1006 CX | Netherlands |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 CX | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Streekziekenhuizen Gooi-Noord | Blaricum | 1261 AN | Netherlands |
| Amphia Ziekenhuis - locatie Molengracht | Breda | 4818 CK | Netherlands |
| Atrium Medisch Centrum - Brunssum | Brunssum | 6442 BE | Netherlands |
| Reinier de Graaf Group | Delft | NL 2600 GA | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5602 ZA | Netherlands |
| Medisch Spectrum Twente | Enschede | 7500 KA | Netherlands |
| Academisch Ziekenhuis Groningen | Groningen | 9713 EZ | Netherlands |
| Atrium Medical Centre | Heerlen | 6419 PC | Netherlands |
| Radiotherapeutisch Instituut | Leeuwarden | 8934 AD | Netherlands |
| Diaconessenhuis Leiden | Leiden | 2300 RD | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| Sint Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| University Medical Center Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| Maasland Hospital | Sittard | 6131 BK | Netherlands |
| Leyenburg Ziekenhuis | The Hague | 2545 CH | Netherlands |
| Academisch Ziekenhuis Utrecht | Utrecht | 3584 CX | Netherlands |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Instituto Portugues de Oncologia Centro do Porto, SA | Porto | 4200 | Portugal |
| National Cancer Institute - Bratislava | Bratislava | 833 10 | Slovakia |
| Institute of Oncology, Ljubljana | Ljubljana | Sl-1000 | Slovenia |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| 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. |
| Result | 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. |
| 29229324 | Derived | 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. |
| 28601705 | 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. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| C034632 | ABVD protocol |
| D015251 | Epirubicin |
| D011241 | Prednisone |
| D014747 | Vinblastine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013812 | Therapeutics |
Not provided
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