Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease

NCT00002827 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2013-08-26

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.

Conditions

Interventions

BIOLOGICAL

bleomycin sulfate

Given IV

BIOLOGICAL

filgrastim

Given IV

DRUG

dexrazoxane hydrochloride

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

etoposide

Given IV

DRUG

vincristine sulfate

Given IV

RADIATION

low-LET cobalt-60 gamma ray therapy

RADIATION

low-LET electron therapy

RADIATION

low-LET photon therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Children's Cancer Group

    collaborator OTHER
  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Cameron K. Tebbi, MD · St. Joseph's Children's Hospital of Tampa

  • Michael A. Weiner, MD · Herbert Irving Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-10-31
Primary Completion
2004-10-31
Completion
2008-06-30

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002827 on ClinicalTrials.gov