Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Previously Untreated Stage I or Stage II Hodgkin's Lymphoma

NCT00379041 | Active Not Recruiting Phase 3

• 2 other identifiers: EORTC-20931EORTC-20931-LYMG
• Study Type: interventional
• Target: 1,158
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. 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 radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

• Overall survival

• Reduction of late treatment-related toxicity

• Maintenance of failure-free survival rate

Interventions

bleomycin sulfate BIOLOGICAL

doxorubicin hydrochloride DRUG

mechlorethamine hydrochloride DRUG

prednisone DRUG

procarbazine hydrochloride DRUG

vinblastine sulfate DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed supradiaphragmatic Hodgkin's lymphoma * Stage I or II disease * Previously untreated disease PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Normal life expectancy * No severe cardiac, pulmonary, neurologic, or metabolic disease that would interfere with normal life expectancy or study treatment * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No psychological, familial, socioeconomic, or geographic circumstance that would preclude proper staging or study compliance * HIV negative * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior staging laparotomy * No prior biologic therapy, chemotherapy, endocrine therapy, radiotherapy, or surgery for this malignancy

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Related Publications (3)

• Heutte N, Flechtner HH, Mounier N, Mellink WA, Meerwaldt JH, Eghbali H, van't Veer MB, Noordijk EM, Kluin-Nelemans JC, Lampka E, Thomas J, Lugtenburg PJ, Viterbo L, Carde P, Hagenbeek A, van der Maazen RW, Smit WG, Brice P, van Marwijk Kooy M, Baars JW, Poortmans P, Tirelli U, Leeksma OC, Tomsic R, Feugier P, Salles G, Gabarre J, Kersten MJ, Van Den Neste E, Creemers GJ, Gaillard I, Meijnders P, Tertian G, Reman O, Muller HP, Troncy J, Blanc M, Schroyens W, Voogt PJ, Wijermans P, Rieux C, Ferme C, Henry-Amar M; EORTC-GELA H8 Trial Group. Quality of life after successful treatment of early-stage Hodgkin's lymphoma: 10-year follow-up of the EORTC-GELA H8 randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1160-70. doi: 10.1016/S1470-2045(09)70258-X. Epub 2009 Oct 12.

  PMID: 19828373 RESULT

• Mounier N, Heutte N, Flechtner H, et al.: Quality of life in early stage Hodgkin lymphoma (HL) patients from the EORTC-GELA H8 Trial (20931): A post-treatment longitudinal study of 1,015 patients. [Abstract] J Clin Oncol 26 (Suppl 15): A-9535, 2008.

  RESULT

• Ferme C, Eghbali H, Meerwaldt JH, Rieux C, Bosq J, Berger F, Girinsky T, Brice P, van't Veer MB, Walewski JA, Lederlin P, Tirelli U, Carde P, Van den Neste E, Gyan E, Monconduit M, Divine M, Raemaekers JM, Salles G, Noordijk EM, Creemers GJ, Gabarre J, Hagenbeek A, Reman O, Blanc M, Thomas J, Vie B, Kluin-Nelemans JC, Viseu F, Baars JW, Poortmans P, Lugtenburg PJ, Carrie C, Jaubert J, Henry-Amar M; EORTC-GELA H8 Trial. Chemotherapy plus involved-field radiation in early-stage Hodgkin's disease. N Engl J Med. 2007 Nov 8;357(19):1916-27. doi: 10.1056/NEJMoa064601.

  PMID: 17989384 RESULT

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Doxorubicin; Mechlorethamine; Prednisone; Procarbazine; Vinblastine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• H. Eghbali, MD

  Institut Bergonié

  STUDY CHAIR

• Christophe Ferme

  Centre Medical de Bligny

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: September 1, 1993
• Primary Completion: October 1, 1998
• Last Updated: August 5, 2025

Record last verified: 2025-08