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Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer

NCT00003994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2013-06-14

No results posted yet for this study

Summary

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is most effective for children and young adults with liver cancer. This randomized phase III trial is studying giving combination chemotherapy together with amifostine to see how well it works compared to combination chemotherapy alone in treating patients with liver cancer.

Conditions

  • Childhood Hepatoblastoma
  • Recurrent Childhood Liver Cancer
  • Stage I Childhood Liver Cancer

Interventions

PROCEDURE

therapeutic conventional surgery

Undergo surgical resection

DRUG

cisplatin

Given IV

DRUG

vincristine sulfate

Given IV

DRUG

fluorouracil

Given IV

DRUG

amifostine trihydrate

Given IV

DRUG

carboplatin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Howard Katzenstein · 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
1999-03-31
Primary Completion
2007-10-31

Countries

  • United States

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 NCT00003994 on ClinicalTrials.gov