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Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer

NCT00980460 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-05-04

Study results available
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Summary

This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary, liver transplant, are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.

Conditions

  • PRETEXT I Hepatoblastoma
  • PRETEXT II Hepatoblastoma
  • PRETEXT III Hepatoblastoma
  • PRETEXT IV Hepatoblastoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Dexrazoxane

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Liver Transplantation

Undergo liver transplant

DRUG

Temsirolimus

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Howard M Katzenstein · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-14
Primary Completion
2020-06-30
Completion
2027-03-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Japan
  • Puerto Rico

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 NCT00980460 on ClinicalTrials.gov