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Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: May 2, 2000   Last Updated: April 18, 2009   History of Changes
Sponsors and Collaborators: European Organization for Research and Treatment of Cancer
Groupe d'Etudes de Lymphomes de L'Adulte
Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005584
  Purpose

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.


Condition Intervention Phase
Lymphoma
 Biological: bleomycin sulfate
Drug: ABVD regimen
Drug: BEACOPP regimen
Drug: epirubicin hydrochloride
Drug: prednisone
Drug: vinblastine
Radiation: radiation therapy
 Phase III

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma Radiation Therapy
Drug Information available for: Prednisone Bleomycin Epirubicin hydrochloride Epirubicin Vinblastine sulfate Vinblastine Bleomycin sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups

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

Study Start Date: October 1998
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Randomized groups: Histologically proven previously untreated stage I or II supradiaphragmatic Hodgkin's lymphoma

    • No prior staging laparotomy
    • Favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognosis

  • Nonrandomized group: Histologically proven lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma)

    • Stage I with complete or incomplete resection OR
    • Stage II

PATIENT CHARACTERISTICS:

Age:

  • 15 to 70

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No severe cardiac disease that would interfere with normal life expectancy or study treatment

Pulmonary:

  • No severe pulmonary disease that would interfere with normal life expectancy or study treatment

Other:

  • No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No severe neurologic or metabolic disease that would interfere with normal life expectancy or study treatment
  • No psychologic, familial, socioeconomic, or geographic circumstances that would preclude proper staging or compliance
  • HIV negative
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for this malignancy

Chemotherapy

  • No prior chemotherapy for this malignancy

Endocrine therapy

  • No prior endocrine therapy for this malignancy

Radiotherapy

  • No prior radiotherapy for this malignancy

Surgery

  • No prior surgery for this malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005584

  Show 121 Study Locations
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Groupe d'Etudes de Lymphomes de L'Adulte
Federation Nationale des Centres de Lutte Contre le Cancer
Investigators
Investigator: Jose Thomas, MD U.Z. Gasthuisberg
Investigator: H. Eghbali, MD Institut Bergonie
Investigator: E.M. Noordijk, MD Leiden University Medical Center
Investigator: Christophe Ferme Centre Medical de Bligny
Investigator: Christian Gisselbrecht, MD Hopital Saint-Louis
Investigator: Thierry O. Philip, MD Centre Leon Berard
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.
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.
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.
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.
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.
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.
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. Epub 2007 May 21.

Study ID Numbers: CDR0000067652, EORTC-20982, FRE-FNCLCC-98014, GELA-H9
Study First Received: May 2, 2000
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00005584     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
adult lymphocyte predominant Hodgkin lymphoma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hodgkin Lymphoma, Adult
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Quality of Life
Hodgkin's Disease
Vinblastine
Antimitotic Agents
 Hormones
Glucocorticoids
Epirubicin
Bleomycin
Lymphatic Diseases
Anti-Bacterial Agents
Tubulin Modulators
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vinblastine
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Lymphoma
Hodgkin Disease
Immunoproliferative Disorders
Neoplasms by Histologic Type
 Immune System Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Antimitotic Agents
Epirubicin
Bleomycin
Glucocorticoids
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009



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