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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

Information source: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological); doxorubicin hydrochloride (Drug); mechlorethamine hydrochloride (Drug); prednisone (Drug); procarbazine hydrochloride (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug); radiation therapy (Radiation)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: European Organisation for Research and Treatment of Cancer - EORTC

Official(s) and/or principal investigator(s):
H. Eghbali, MD, Study Chair, Affiliation: Institut Bergonié
Christophe Ferme, Study Chair, Affiliation: Centre Medical de Bligny

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.

Clinical Details

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]

Study design: Allocation: Randomized, Primary Purpose: Treatment

Primary outcome:

Overall survival

Reduction of late treatment-related toxicity

Maintenance of failure-free survival rate

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

Minimum age: 15 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 1993
Last updated: February 10, 2015

Page last updated: August 23, 2015

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