Phase 3 Study of Modified PHITT Treatment for Children With Newly Diagnosed Hepatoblastoma Including Randomized Sodium Thiosulfate to Protect Hearing in Localized Disease And Response-Based Therapy for Metastatic Disease

What this Trial Is About

Researchers are conducting a Phase 3 multi-institutional study to treat children newly diagnosed with hepatoblastoma, a type of liver cancer. The study evaluates a modified Pediatric Hepatic International Tumor Trial PHITT strategy, including a randomized assessment of sodium thiosulfate STS to protect hearing in children with localized disease. It also investigates response-adapted therapy for patients with metastatic disease, aiming to improve event-free survival and assess treatment effects on hearing and tumor response. Children are divided into four groups based on tumor characteristics and treatment needs. Group A includes patients with tumors completely removed at diagnosis, receiving either no further chemotherapy or two cycles of cisplatin. Group B receives cisplatin monotherapy, with or without STS, and Group C receives a combination chemotherapy regimen, also with or without STS. Group D includes patients with metastatic disease who receive induction chemotherapy followed by response-adapted consolidation therapy. Surgery to remove tumors or pulmonary nodules is scheduled at specific times during treatment based on response. Participants will undergo regular assessments including audiograms to monitor hearing and evaluations of event-free survival for up to three years. Researchers will also monitor treatment-related side effects and tumor response. Tumor, blood, and urine samples will be collected for biological studies. The total participation time includes treatment cycles, surgery, follow-up evaluations, and up to three years of monitoring for outcomes and safety.

A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy