NCT00433433

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,952

participants targeted

Target at P75+ for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

5.2 years

First QC Date

February 8, 2007

Last Update Submit

February 2, 2021

Conditions

Lymphoma

Keywords

adult mixed cellularity Hodgkin lymphomaadult nodular sclerosis Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomaadult lymphocyte depletion Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (3)

  • Event-free survival

  • Overall survival

  • Long-term toxicity, in terms of secondary malignancies, cardiovascular events, and pulmonary events

Study Arms (6)

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.

Drug: ABVD q4 weeksRadiation: IN-RT 30 Gy (+ boost 6 Gy residual)Procedure: FDG-PET scan

Favorable - Experimental - PET negative

EXPERIMENTAL

ABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx2 without further RT (total of 4 cycles!)

Drug: ABVD q4 weeksProcedure: FDG-PET scan

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).

Drug: BEACOPP escalated q3 weeksRadiation: IN-RT 30 Gy (+ boost 6 Gy residual)Procedure: FDG-PET scan

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.

Drug: ABVD q4 weeksRadiation: IN-RT 30 Gy (+ boost 6 Gy residual)Procedure: FDG-PET scan

Unfavorable - Experimental - PET negative

EXPERIMENTAL

ABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx 4 cycles, without RT (total of 6 cycles)

Drug: ABVD q4 weeksProcedure: FDG-PET scan

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).

Drug: BEACOPP escalated q3 weeksRadiation: IN-RT 30 Gy (+ boost 6 Gy residual)Procedure: FDG-PET scan

Interventions

ABVD q4 weeksDRUG

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

Favorable - Experimental - PET negativeFavorable - Standard - any PET outcomeUnfavorable - Experimental - PET negativeUnfavorable - Standard - Any PET outcome
BEACOPP escalated q3 weeksDRUG

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

Favorable - Experimental - PET positiveUnfavorable - Experimental - PET positive
IN-RT 30 Gy (+ boost 6 Gy residual)RADIATION
Also known as: Involved-Note Radiation Therapy
Favorable - Experimental - PET positiveFavorable - Standard - any PET outcomeUnfavorable - Experimental - PET positiveUnfavorable - Standard - Any PET outcome
FDG-PET scanPROCEDURE
Also known as: F-18 fluorodeoxyglucose positron emission tomography scan
Favorable - Experimental - PET negativeFavorable - Experimental - PET positiveFavorable - Standard - any PET outcomeUnfavorable - Experimental - PET negativeUnfavorable - Experimental - PET positiveUnfavorable - Standard - Any PET outcome

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma * No nodular lymphocyte-predominant subtype (nodular paragranuloma) * 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 * Mediastinum and hili are considered as 1 nodal area * 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: * Clinical stage I disease OR stage II disease with ≤ 3 involved areas * Age \< 50 years * ESR \< 50 mm/hr (no B symptoms) OR ESR \< 30 mm/hr (B symptoms present) * MT ratio \< 0.35 * Previously untreated disease * Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-3 * Bilirubin ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No severe cardiac, pulmonary, neurologic, psychiatric, or metabolic disease * No unstable diabetes mellitus * No other malignancies within the past 5 years except for basal cell skin cancer or adequately treated carcinoma in situ of the cervix * No known HIV infection * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Related Publications (6)

  • 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.

    RESULT

  • 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.

    PMID: 40135712DERIVED

  • 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.

    PMID: 39774828DERIVED

  • 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.

    PMID: 36541117DERIVED

  • 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.

    PMID: 29437590DERIVED

  • 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.

    PMID: 24637998DERIVED

MeSH Terms

Conditions

LymphomaHodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2011

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

NL(1)