Risk-Based Treatment for Young Patients with Newly Diagnosed Liver Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT00980460

Provider View

This study is exploring how well a treatment plan based on risk levels works for young patients with newly diagnosed liver cancer. The treatment includes surgery, chemotherapy, and possibly a liver transplant, depending on the cancer stage. The goal is to effectively treat the cancer while minimizing side effects.

Patient Parameters

Program Overview

This phase III trial is investigating the effectiveness and side effects of a risk-based treatment approach for young patients with newly diagnosed liver cancer, specifically hepatoblastoma. The treatment plan includes surgery, chemotherapy, and potentially a liver transplant, depending on the cancer's stage. By tailoring the treatment to the patient's risk group, the study aims to eliminate the cancer, prevent its return, and reduce chemotherapy side effects.

Description

Primary Objectives:

  • To estimate how long children with certain stages of liver cancer remain free from cancer after surgery and chemotherapy.
  • To see if adding a drug called doxorubicin to the chemotherapy plan is safe for children with intermediate-risk liver cancer.
  • To measure how well a combination of drugs works in children with high-risk, metastatic liver cancer.
  • To ensure that most patients with difficult-to-remove liver cancer can consult with a specialized treatment center in a timely manner.
  • To collect tumor and biological samples for future research.

Secondary Objectives:

  • To estimate how long patients with a specific type of stage I liver cancer remain cancer-free after surgery alone.
  • To determine if a liver transplant can be done after initial chemotherapy.
  • To estimate the 2-year cancer-free survival for patients who are candidates for a liver transplant.
  • To register children who receive a liver transplant in an international registry.
  • To see if a specific grouping system can predict if the tumor can be removed.
  • To monitor the agreement between local and expert assessments of tumor grouping.
  • To estimate how many stage IV patients have surgery to remove lung tumors.
  • To determine the outcomes for patients with certain poor prognostic factors.

Treatment Groups:

  • Very Low-Risk Group: Patients have surgery and no further treatment.
  • Low-Risk Group: Patients have surgery followed by chemotherapy with cisplatin, fluorouracil, and vincristine.
  • Intermediate-Risk Group: Patients receive chemotherapy with cisplatin, fluorouracil, vincristine, and doxorubicin, followed by surgery or liver transplant.
  • High-Risk Group: Patients receive chemotherapy with vincristine, irinotecan, and temsirolimus, followed by additional chemotherapy and surgery or liver transplant.

After completing the study treatment, patients who received chemotherapy will be monitored periodically for at least 4 years.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with liver cancer (hepatoblastoma).
  • In urgent cases, patients can join the study without a biopsy if they meet other criteria and have a clinical diagnosis.
  • Patients must be staged for risk classification using specific guidelines.
  • Treatment plan must be identified at enrollment.
  • Patients must have a performance status score of 0, 1, or 2.
  • Organ function requirements are not needed for patients with stage I, PFH who will not receive chemotherapy.
  • Specific blood and organ function levels must be met.
  • Patients with seizure disorders can join if seizures are controlled.
  • Must sign informed consent and meet all regulatory requirements.

Exclusion Criteria

  • Patients with stage I or II disease without required pathology review.
  • Previously treated with chemotherapy or other liver cancer therapies.
  • Currently receiving another investigational drug or anticancer agents.
  • Previous solid organ transplant recipients.
  • Uncontrolled infections.
  • Pregnant or breastfeeding females.
  • Patients not using effective contraception.
  • Receiving corticosteroids or certain medications affecting liver enzymes.
  • Receiving therapeutic anticoagulants or ACE inhibitors.
  • Recent major surgery within 6 weeks prior to enrollment.

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