Radiation Therapy With or Without Combination Chemotherapy 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 October 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00379041
First received: September 20, 2006
Last updated: November 2, 2010
Last verified: October 2009
  Purpose

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
Lymphoma
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Reduction of late treatment-related toxicity [ Designated as safety issue: Yes ]
  • Maintenance of failure-free survival rate [ Designated as safety issue: No ]

Estimated Enrollment: 1158
Study Start Date: September 1993
Detailed Description:

OBJECTIVES:

  • Evaluate the efficacy of mantle field radiotherapy, in terms of overall survival, in patients with previously untreated stage I or II Hodgkin's lymphoma (HL) with a very favorable prognosis.
  • Compare late treatment-related toxicity in patients with stage I or II HL with a favorable prognosis treated with standard subtotal nodal radiotherapy vs a combination of 3 courses of mechlorethamine, vincristine, procarbazine hydrochloride, prednisone/doxorubicin hydrochloride, bleomycin, and vinblastine (MOPP/ABV) followed by involved field radiotherapy.
  • Compare overall survival and late treatment-related toxicity in patients with stage I or II HL with an unfavorable prognosis treated with 6 courses of MOPP/ABV followed by involved field radiotherapy vs 4 courses of MOPP/ABV followed by involved field radiotherapy vs subtotal nodal radiotherapy.
  • Maintain the failure-free survival rate that was reached in previous studies, with a reduction of the acute side effects of the treatment, particularly severe late toxicity.

OUTLINE: This is a randomized, controlled, prospective, multicenter study. Patients are stratified according to prognosis (favorable vs unfavorable vs very favorable).

  • Stratum 1 (very favorable prognosis): Patients undergo mantle field radiotherapy 5 days a week for at least 4 weeks.
  • Stratum 2 (favorable prognosis): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients undergo subtotal nodal radiotherapy 5 days a week for at least 4 weeks.
    • Arm II: Patients receive mechlorethamine IV and vincristine IV on day 1; oral procarbazine hydrochloride on days 1-7; oral prednisone on days 1-14; and doxorubicin hydrochloride IV, bleomycin intramuscularly (IM) or IV, and vinblastine IV on day 8. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of chemotherapy, patients undergo involved field radiotherapy 5 days a week for at least 4 weeks.
  • Stratum 3 (unfavorable prognosis): Patients are randomized to 1 of 3 treatment arms.

    • Arm I: Patients receive mechlorethamine IV and vincristine IV on day 1; oral procarbazine hydrochloride on days 1-7; oral prednisone on days 1-14; and doxorubicin hydrochloride IV, bleomycin IM or IV, and vinblastine IV on day 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of chemotherapy, patients undergo involved field radiotherapy 5 days a week for at least 4 weeks.
    • Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo involved field radiotherapy as in arm I.
    • Arm III: Patients receive chemotherapy as in arm I. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks after completion of chemotherapy, patients undergo subtotal nodal radiotherapy 5 days a week for at least 4 weeks.

Quality of life is assessed after completion of study treatment and then annually for 10 years.

After completion of study treatment, patients are followed at 2, 4, 6, 9, and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,158 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 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
  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 ClinicalTrials.gov identifier: NCT00379041

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

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00379041     History of Changes
Other Study ID Numbers: CDR0000504418, EORTC-20931
Study First Received: September 20, 2006
Last Updated: November 2, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult 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
Mechlorethamine
Prednisone
Procarbazine
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators

ClinicalTrials.gov processed this record on July 22, 2014