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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-20051 | |||
| GELA-H10 | |||
| IIL-EORTC-20051 | |||
| EUDRACT-2005-002765-37 | |||
| EU-20657 |
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| Name | Class |
|---|---|
| Lymphoma Study Association | OTHER |
| Fondazione Italiana Linfomi - ETS | OTHER |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET scan), may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET scan-guided therapy is more effective than standard therapy in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying FDG-PET scan-guided therapy to see how well it works compared with standard therapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease prognostic profile (favorable vs unfavorable), participating center, Ann Arbor clinical stage (I vs II), and availability of a baseline fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I (standard [closed to accrual as of 6/24/2011]): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV or intramuscularly (IM), vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with favorable prognostic profile receive 3 courses of ABVD. Patients with unfavorable prognostic profile receive 4 courses of ABVD. Patients undergo FDG-PET scan after completion of 2 courses of ABVD. Beginning 3-4 weeks after completion of ABVD, patients undergo involved-node radiotherapy (INRT) 5 days a week for 4-6 weeks.
Arm II (experimental): Patients receive ABVD as in arm I for 2 courses and then undergo FDG-PET scan. Further treatment is adapted according to FDG-PET scan result.
After completion of study treatment, patients are followed periodically for at least 10 years.
PROJECTED ACCRUAL: A total of 1,797 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favorable - Standard - any PET outcome | Active Comparator | ABVDx3 cycles + Involved node RT (IN-RT) 30 Gy (+boost of 6Gy to residual lesions); FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place. |
|
| Favorable - Experimental - PET negative | Experimental | ABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx2 without further RT (total of 4 cycles!) |
|
| Favorable - Experimental - PET positive | Experimental | ABVDx2 cycles; then FDG-PET evaluation: PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT30Gy (+boost 6Gy to residual lesions). |
|
| Unfavorable - Standard - Any PET outcome | Active Comparator | ABVDx4 cycles + IN-RT 30Gy (+boost 6Gy to residual lesions). FDG-PET after two cycles of ABVD for comparison with the experimental arm will be performed but no treatment adaptation will take place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABVD q4 weeks | Drug | Doxorubicin 25 mg/m2 i.v. day 1 and 15; Bleomycin 10 mg/m2 i.v./i.m. day 1 and 15; Vinblastine 6 mg/m2 i.v. day 1 and 15; Dacarbazine 375 mg/m2 i.v. day 1 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | ||
| Overall survival | ||
| Long-term toxicity, in terms of secondary malignancies, cardiovascular events, and pulmonary events |
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DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma
Supradiaphragmatic Ann Arbor clinical stage I or II disease
Must meet criteria for 1 of the following prognostic subsets:
Unfavorable subset, defined as meeting 1 of the following criteria:
Clinical stage II disease with ≥ 4 nodal areas involved
Age ≥ 50 years
Erythrocyte sedimentation rate (ESR) ≥ 50 mm/hr with no B symptoms
ESR ≥ 30 mm/hr with B symptoms
Mediastinum/thoracic (MT) ratio ≥ 0.35
Favorable subset, defined as meeting all of the following criteria:
Previously untreated disease
Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| John Raemaekers, MD, PhD | EORTC - Universitair Medisch Centrum St. Radboud, Nijmegen, NL | Principal Investigator |
| H. Eghbali, MD | EORTC - Institut Bergonie, Bordeaux, FR | Study Chair |
| Marc Andre, MD | GELA - Centre Hospitalier Notre Dame - Reine Fabiola, Brussels, BE | Principal Investigator |
| Oumedaly Reman, MD | GELA - CHU de Caen, Caen, FR | Study Chair |
| Massimo Federico, MD | GIMEMA- Azienda Ospedaliera - Universitaria di Modena, Modena, IT | Principal Investigator |
| Ercole Brusamolino, MD | GIMEMA - Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, IT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | André M, Reman O, Fédérico M, et al.: First report on the H10 EORTC/GELA/IIL randomized intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supra-diaphragmatic stage I/II Hodgkin's lymphoma, for the Groupe d'Etude Des Lymphomes De l'Adulte (GELA), European Organisation for the Research and Treatment of Cancer (EORTC) Lymphoma Group and the Intergruppo Italiano Linfomi (IIL) . [Abstract] Blood 114 (22): A-97, 2009. | ||
| 40135712 | Derived | Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3. | |
| 39774828 |
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| Unfavorable - Experimental - PET negative | Experimental | ABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx 4 cycles, without RT (total of 6 cycles) |
|
| Unfavorable - Experimental - PET positive | Experimental | ABVDx2 cycles; then FDG-PET evaluation: PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT 30Gy (+boost 6Gy to residual lesions). |
|
| BEACOPP escalated q3 weeks | Drug | Cyclophosphamide 1250 mg/m2 i.v. day 1; Doxorubicin 35 mg/m2 i.v. day 1; Vincristine 1.4 mg/m2 i.v.(max.2mg) day 8; Bleomycin 10 mg/m2 i.v./i.m. day 8; Etoposide 200 mg/m2/ i.v. day 1 to 3; Procarbazine 100 mg/m2 orally day 1 to 7; Prednisone 40 mg/m2 orally day 1 to 14; G-CSF 5 mcg/kg s.c. day 9 to recovery leukocytes>1.0x109/l |
|
| IN-RT 30 Gy (+ boost 6 Gy residual) | Radiation |
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| FDG-PET scan | Procedure |
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| Derived |
| Phillips EH, Counsell N, Illidge T, Andre M, Aurer I, Fiaccadori V, Fortpied C, Neven A, Federico M, Barrington SF, Raemaekers J, Radford J. Maximum tumor diameter is associated with relapse risk in limited-stage Hodgkin lymphoma: an international study. Blood Adv. 2025 May 13;9(9):2266-2274. doi: 10.1182/bloodadvances.2024015140. |
| 36541117 | Derived | Fiaccadori V, Neven A, Fortpied C, Aurer I, Andre M, Federico M, Counsell N, Phillips EH, Clifton-Hadley L, Barrington SF, Illidge T, Radford J, Raemaekers JMM. Relapse patterns in early-PET negative, limited-stage Hodgkin lymphoma (HL) after ABVD with or without radiotherapy-a joint analysis of EORTC/LYSA/FIL H10 and NCRI RAPID trials. Br J Haematol. 2023 Mar;200(6):731-739. doi: 10.1111/bjh.18594. Epub 2022 Dec 21. |
| 29437590 | Derived | Cottereau AS, Versari A, Loft A, Casasnovas O, Bellei M, Ricci R, Bardet S, Castagnoli A, Brice P, Raemaekers J, Deau B, Fortpied C, Raveloarivahy T, Van Zele E, Chartier L, Vander Borght T, Federico M, Hutchings M, Ricardi U, Andre M, Meignan M. Prognostic value of baseline metabolic tumor volume in early-stage Hodgkin lymphoma in the standard arm of the H10 trial. Blood. 2018 Mar 29;131(13):1456-1463. doi: 10.1182/blood-2017-07-795476. Epub 2018 Feb 1. |
| 24637998 | Derived | Raemaekers JM, Andre MP, Federico M, Girinsky T, Oumedaly R, Brusamolino E, Brice P, Ferme C, van der Maazen R, Gotti M, Bouabdallah R, Sebban CJ, Lievens Y, Re A, Stamatoullas A, Morschhauser F, Lugtenburg PJ, Abruzzese E, Olivier P, Casasnovas RO, van Imhoff G, Raveloarivahy T, Bellei M, van der Borght T, Bardet S, Versari A, Hutchings M, Meignan M, Fortpied C. Omitting radiotherapy in early positron emission tomography-negative stage I/II Hodgkin lymphoma is associated with an increased risk of early relapse: Clinical results of the preplanned interim analysis of the randomized EORTC/LYSA/FIL H10 trial. J Clin Oncol. 2014 Apr 20;32(12):1188-94. doi: 10.1200/JCO.2013.51.9298. Epub 2014 Mar 17. |
| 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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