MedTrace Logo

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

NCT00025259 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1734

Last updated 2017-04-12

Study results available
· View outcomes & findings →

Summary

This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.

Conditions

  • Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma
  • Childhood Mixed Cellularity Classical Hodgkin Lymphoma
  • Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
  • Childhood Nodular Sclerosis Classical Hodgkin Lymphoma
  • Stage I Childhood Hodgkin Lymphoma
  • Stage II Childhood Hodgkin Lymphoma
  • Stage III Childhood Hodgkin Lymphoma
  • Stage IV Childhood Hodgkin Lymphoma

Interventions

BIOLOGICAL

Bleomycin Sulfate

Given IV or SC

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV

DRUG

Dexamethasone

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

RADIATION

Involved-Field Radiation Therapy

Undergo IFRT

DRUG

Prednisone

Given orally

DRUG

Vincristine Sulfate Liposome

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Debra Friedman · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2012-08-31

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • New Zealand
  • Puerto Rico
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00025259 on ClinicalTrials.gov