The Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) directly addresses the need for the next generation of clinical trials for hepatic malignancies, incorporating rational reductions in therapy that ameliorate both short and long-term side effects for patients with good prognoses while simultaneously optimizing curative potential with intensification and new agent integration to improve outcomes for those with poor prognoses. This trial is the first international cooperative liver tumors trial in which a consensus approach was established by investigators representing Children's Oncology Group (COG), Societe Internationale d'Oncologie Pediatrique - Epithelial Liver Tumor Study Group (SIOPEL) and the Japanese Children's Cancer Group (JCCG). The study builds on treatment strategies established by the most recent trials from each of the individual consortia - COG (AHEP0731 ), SIOPEL (SIOPEL 3 and 4) and Japanese Pediatric Liver Tumor study group (JPLT2), but provides new approaches to all stages of HB and HCC patients keeping the aforementioned goals in focus. A critical aspect of this trial is the opportunity to correlate histologic and biologic heterogeneity with response and outcomes in all risk categories, providing promise for future refinement to the newly proposed risk stratification schema.
Inclusion Criteria
- Patients must have a performance status coF responding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients greater than 16 years of age and Lansky for patients less than or equal to 16 years of age.
- Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma (there are exceptions)
Exclusion Criteria
- Prior chemotherapy or tumor directed therapy except for surgical resection of the hepatic malignancy (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.
Study Requirements
Treatment will be dependent on which arm you are randomized to. Cycles of Chemo will range from 2-6. Those who qualify will have resection at appropriate time points. There will be imaging throughout to monitor the success of chemo or resction. There will also be an optional biology study that will require biopsies and blood draws at various times.
