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

February 21, 2024 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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]

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1158

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival
Reduction of late treatment-related toxicity
Maintenance of failure-free survival rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: H. Eghbali, MD, Institut Bergonié
  • Study Chair: Christophe Ferme, Centre Medical de Bligny

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 1993

Primary Completion (Actual)

October 1, 1998

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimated)

September 21, 2006

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-20931
  • EORTC-20931-LYMG (Other Identifier: EORTC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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