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NCT00433433 · CITED IN SOURCE DOCUMENTS

Fludeoxyglucose F 18 PET Scan-Guided Therapy or Standard Therapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2021-02-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
70 Years
minimum Age
15 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: ABVD q4 weeks
    2. Radiation: IN-RT 30 Gy (+ boost 6 Gy residual)
    3. Procedure: FDG-PET scan
    label
    Favorable - Standard - any PET outcome
    type
    ACTIVE_COMPARATOR
  2. description
    ABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx2 without further RT (total of 4 cycles!)
    intervention Names
    1. Drug: ABVD q4 weeks
    2. Procedure: FDG-PET scan
    label
    Favorable - Experimental - PET negative
    type
    EXPERIMENTAL
  3. description
    ABVDx2 cycles; then FDG-PET evaluation: PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT30Gy (+boost 6Gy to residual lesions).
    intervention Names
    1. Drug: BEACOPP escalated q3 weeks
    2. Radiation: IN-RT 30 Gy (+ boost 6 Gy residual)
    3. Procedure: FDG-PET scan
    label
    Favorable - Experimental - PET positive
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Drug: ABVD q4 weeks
    2. Radiation: IN-RT 30 Gy (+ boost 6 Gy residual)
    3. Procedure: FDG-PET scan
    label
    Unfavorable - Standard - Any PET outcome
    type
    ACTIVE_COMPARATOR
  5. description
    ABVDx2 cycles; then FDG-PET evaluation: PET negative: ABVDx 4 cycles, without RT (total of 6 cycles)
    intervention Names
    1. Drug: ABVD q4 weeks
    2. Procedure: FDG-PET scan
    label
    Unfavorable - Experimental - PET negative
    type
    EXPERIMENTAL
  6. description
    ABVDx2 cycles; then FDG-PET evaluation: PET positive: presumed poor-risk: switch to escalated BEACOPPx2 + INRT 30Gy (+boost 6Gy to residual lesions).
    intervention Names
    1. Drug: BEACOPP escalated q3 weeks
    2. Radiation: IN-RT 30 Gy (+ boost 6 Gy residual)
    3. Procedure: FDG-PET scan
    label
    Unfavorable - Experimental - PET positive
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Favorable - Experimental - PET negative
    2. Favorable - Standard - any PET outcome
    3. Unfavorable - Experimental - PET negative
    4. Unfavorable - Standard - Any PET outcome
    description
    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
    name
    ABVD q4 weeks
    type
    DRUG
  2. arm Group Labels
    1. Favorable - Experimental - PET positive
    2. Unfavorable - Experimental - PET positive
    description
    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
    name
    BEACOPP escalated q3 weeks
    type
    DRUG
  3. arm Group Labels
    1. Favorable - Experimental - PET positive
    2. Favorable - Standard - any PET outcome
    3. Unfavorable - Experimental - PET positive
    4. Unfavorable - Standard - Any PET outcome
    name
    IN-RT 30 Gy (+ boost 6 Gy residual)
    other Names
    1. Involved-Note Radiation Therapy
    type
    RADIATION
  4. arm Group Labels
    1. Favorable - Experimental - PET negative
    2. Favorable - Experimental - PET positive
    3. Favorable - Standard - any PET outcome
    4. Unfavorable - Experimental - PET negative
    5. Unfavorable - Experimental - PET positive
    6. Unfavorable - Standard - Any PET outcome
    name
    FDG-PET scan
    other Names
    1. F-18 fluorodeoxyglucose positron emission tomography scan
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1952
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-free survival
secondary Outcomes
  1. measure
    Event-free survival
  2. measure
    Overall survival
  3. measure
    Long-term toxicity, in terms of secondary malignancies, cardiovascular events, and pulmonary events
Full study description
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.
detailed Description
OBJECTIVES: Primary * Evaluate whether chemotherapy alone is as effective, but less toxic, as combined modality treatment, in terms of progression-free survival (PFS), in patients with favorable or unfavorable supradiaphragmatic stage I or II Hodgkin's lymphoma who are fludeoxglucose F 18 positron emission tomography (FDG-PET) scan negative after two courses of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD). Secondary * Evaluate whether early change of chemotherapy from ABVD to escalated cyclophosphamide, doxorubicin hydrochloride, vincristine, bleomycin, etoposide, procarbazine hydrochloride, and prednisone (escalated BEACOPP) improves the PFS of patients who are FDG-PET scan positive after two courses of ABVD. * Confirm that early response by FDG-PET scan is predictive of the outcome of patients randomized to the standard treatment arm. 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. * FDG-PET negative: Patients with favorable prognostic profile receive 1 additional courses of ABVD. Patients with unfavorable prognostic profile receive 2 additional courses of ABVD. Patients with favorable or unfavorable prognostic profiles randomized on or after August 9th 2010 who are FDG-PET negative after two courses of ABVD will receive standard combined modality treatment consisting of ABVD and INRT as in arm I. * FDG-PET positive: Patients receive ABVD as in arm I for 2 courses or intensification to escalated BEACOPP chemotherapy comprising cyclophosphamide IV and doxorubicin hydrochloride IV on day 1, vincristine IV and bleomycin IV or IM on day 8, etoposide IV on days 1-3, oral procarbazine hydrochloride on days 1-7, oral prednisone on days 1-14, and filgrastim (G-CSF) subcutaneously beginning on day 9 and continuing until blood count recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of ABVD or BEACOPP, patients undergo INRT 5 days a week for 4-6 weeks. 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.
Source references
references
  1. citation
    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.
    type
    RESULT
  2. citation
    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
    40135712
    type
    DERIVED
  3. citation
    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
    39774828
    type
    DERIVED
  4. citation
    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
    36541117
    type
    DERIVED
  5. citation
    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
    29437590
    type
    DERIVED
  6. citation
    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
    24637998
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        (PET) scans for early favorable HL.</p> <div class="pdq-content-list"><ol id="_1126"><li>Three prospective randomized trials (<a href="/clinicaltrials/NCT00433433">EORTC/LYSA/FIL H10</a> [NCT00433433][<a href="#cit/section_5.14">14</a>,<a href="#cit/section_5.15">15</a>]; <a href="/clinicaltrials/NCT00943423">RAPID</a> [
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        p> <div class="pdq-content-list"><ol id="_1126"><li>Three prospective randomized trials (<a href="/clinicaltrials/NCT00433433">EORTC/LYSA/FIL H10</a> [NCT00433433][<a href="#cit/section_5.14">14</a>,<a href="#cit/section_5.15">15</a>]; <a href="/clinicaltrials/NCT00943423">RAPID</a> [NCT00943423][<a href="#cit/section_5.
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        n the <a href="/clinicaltrials/NCT00943423">RAPID</a> study,[<a href="#cit/section_5.16">16</a>] for four cycles (eight doses) in the <a href="/clinicaltrials/NCT00433433">EORTC/LYSA/FIL H10</a> study,[<a href="#cit/section_5.14">14</a>] and for two cycles (four doses) in the <a href="/clinicaltrials/NCT00736320">GHSG HD16</a> s
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      1. context
        Updated: February 12, 2025
        datetime
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        February 12, 2025

    Preserved source evidence · Not medical advice