Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Recruiting
30 years or below
All
Phase N/A
1 Location

Brief description of study

This trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery.

Detailed description of study

The purpose of this study is to reduce therapy associated toxicity for patients with non-metastatic hepatoblastoma (HB) and hepatocellular carcinoma (HCC) without adversely affecting long term outcomes; and to determine the event-free survival (EFS) in patients with HB whose tumor is completely resected at diagnosis and either receive no adjuvant chemotherapy (completely resected well differentiated fetal histology HB) or 2 cycles of standard dose cisplatin monotherapy (completely resected non-well differentiated fetal histology HB ? 100 mg/m^2/cycle given 3 weeks apart).
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: hepatoblastoma,liver cancer
  • Age: 30 years or below
  • Gender: All

Inclusion Criteria
Patients must be newly diagnosed with hepatoblastoma or hepatocellular carcinoma
Exclusion Criteria
Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection
Patients who previously received a solid organ transplant
This criteria apply ONLY to patients who will receive chemotherapy (all groups other than Group E1):
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Note for Group F: patients of childbearing potential should use effective birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment

Updated on 04 Aug 2024. Study ID: PHO-COG-AHEP1531

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