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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Cisplatin — DRUG
  Given IV
• Dexrazoxane — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Fluorouracil — DRUG
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Liver Transplantation — PROCEDURE
  Undergo liver transplant
• Temsirolimus — DRUG
  Given IV
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo surgery
• Vincristine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Sep 14, 2009

Status verified

Dec 2025

Primary completion

Jun 30, 2020

Completion

Mar 31, 2027

Study Design

Enrollment

236 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: High-risk group (regimen H)
  Patients receive up front VIT chemotherapy comprising vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8. Treatment with VIT repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 4 courses of VIT in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection or liver transplant after course 4 of C5VD followed by 2 courses of adjuvant C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6.
• Experimental: High-risk group (regimen W)
  (regimen W replaced by regimen H as of Amendment 3B) Patients receive up front VI chemotherapy comprising vincristine sulfate IV on days 1 and 8 and irinotecan hydrochloride IV over 90 minutes on days 1-5. Treatment with VI repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease response then receive 6 courses of C5VD with 1 courses of VI in between each 2-course block. Patients with no disease response receive 6 courses of C5VD in the absence of disease progression or unacceptable toxicity.
• Experimental: Intermediate-risk group (regimen F)
  Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012)
• Experimental: Low-risk group (regimen T)
  Patients undergo surgery and then receive adjuvant cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, and vincristine sulfate IV over 1 minute on days 2, 9, and 16. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Very low-risk group
  Patients undergo surgery and then receive no further treatment.

Primary Outcome Measure

Event-free Survival [ Time Frame: Time from patient enrollment to progression, treatment failure, death from any cause, diagnosis of a second malignant neoplasm, or last follow-up, assessed up to 5 years ]

Locations (184)

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