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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Lymphoma Study Association
Intergruppo Italiano Linfomi
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00433433
First received: February 8, 2007
Last updated: July 20, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Biological: filgrastim
Drug: ABVE regimen
Drug: cyclophosphamide
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: The H10 EORTC/GELA/IIL Randomized Intergroup Trial on Early FDG-PET Scan Guided Treatment Adaptation Versus Standard Combined Modality Treatment in Patients With Supradiaphragmatic Stage I/II Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Long-term toxicity, in terms of secondary malignancies, cardiovascular events, and pulmonary events [ Designated as safety issue: Yes ]
  • Response [ Designated as safety issue: No ]

Estimated Enrollment: 1797
Study Start Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433433

Locations
Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen Recruiting
Nijmegen, Netherlands, NL-6500 HB
Contact: John Raemaekers, MD, PhD    31-24-361-4762    J.Raemaekers@hemat.umcn.nl   
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Lymphoma Study Association
Intergruppo Italiano Linfomi
Investigators
Study Chair: John Raemaekers, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
Investigator: H. Eghbali, MD Institut Bergonié
Study Chair: Marc Andre, MD Centre Hospitalier Notre Dame - Reine Fabiola
Investigator: Oumedaly Reman, MD University Hospital, Caen
Study Chair: Massimo Federico, MD Azienda Ospedaliera - Universitaria di Modena
Investigator: Ercole Brusamolino, MD Fondazione I.R.C.C.S. Policlinico San Matteo
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00433433     History of Changes
Other Study ID Numbers: CDR0000531125, EORTC-20051, GELA-H10, IIL-EORTC-20051, EUDRACT-2005-002765-37, EU-20657
Study First Received: February 8, 2007
Last Updated: July 20, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
adult lymphocyte depletion Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Cyclophosphamide
Dacarbazine
Etoposide
Prednisone
Procarbazine
Vinblastine
Vincristine
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 15, 2014