Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

Summary

This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.

Conditions

• Childhood Hepatocellular Carcinoma
• Childhood Malignant Liver Neoplasm
• Fibrolamellar Carcinoma
• Hepatoblastoma
• Hepatocellular Malignant Neoplasm, Not Otherwise Specified

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Doxorubicin

Given IV

DRUG

Etoposide

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Irinotecan

Given IV

DRUG

Oxaliplatin

Given IV

OTHER

Patient Observation

Undergo watchful waiting

PROCEDURE

Resection

Undergo surgical resection

DRUG

Sorafenib

Given PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Gregory M Tiao · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-24

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• New Zealand
• Puerto Rico
• Saudi Arabia

Study Locations