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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC Identifier:
First received: September 20, 2006
Last updated: October 25, 2016
Last verified: October 2016

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.

Condition Intervention Phase
Biological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: mechlorethamine hydrochloride
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial]

Resource links provided by NLM:

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Overall survival
  • Reduction of late treatment-related toxicity
  • Maintenance of failure-free survival rate

Estimated Enrollment: 1158
Study Start Date: September 1993
Primary Completion Date: October 1998 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed supradiaphragmatic Hodgkin's lymphoma

    • Stage I or II disease
  • Previously untreated disease


  • 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


  • No prior staging laparotomy
  • No prior biologic therapy, chemotherapy, endocrine therapy, radiotherapy, or surgery for this malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00379041

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: H. Eghbali, MD Institut Bergonié
Study Chair: Christophe Ferme Centre Medical de Bligny
  More Information

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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00379041     History of Changes
Other Study ID Numbers: EORTC-20931
EORTC-20931-LYMG ( Other Identifier: EORTC )
Study First Received: September 20, 2006
Last Updated: October 25, 2016

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 23, 2017