Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss.
Penelope R Brock, Rudolf Maibach, Margaret Childs...
https://pubmed.ncbi.nlm.nih.gov/29924955Actively Recruiting
Phase 3
Age: 0 - 18Years
All Genders
ID04478292
A Phase 3 Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy Incorporating a Randomized Assessment of Sodium Thiosulfate as Otoprotection for Children With Localized Disease, and Response Adapted Therapy for Patients With Metastatic Disease
Led by Shanghai Children's Medical Center · Updated on 2026-05-04
330
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Shanghai Children's Medical Center
Lead Sponsor
S
Shanghai Children's Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
Who Can Participate
Age: 0 - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients must have performance status ECOG 0, 1, or 2 (Karnofsky for >16 years, Lansky for 616 years)
- Newly diagnosed with histologically confirmed primary pediatric hepatoblastoma
- In emergency cases, patients too ill for biopsy but meeting other criteria may enroll
- Prior surgical removal of the liver tumor allowed before enrollment
- Adequate kidney function with creatinine clearance or GFR 6570 mL/min/1.73 m2
- Adequate liver function with total bilirubin 655 times age limit and AST or ALT less than 10 times age limit
- Adequate lung function if clinically indicated
You will not qualify if you...
- Prior chemotherapy or tumor therapy except surgical removal of liver tumor
- Current use of other investigational drugs
- Current treatment with other anticancer agents
- Uncontrolled infection
- Previous solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 18 weeks or as per group-specific chemotherapy cycles
Participants receive chemotherapy and/or surgery based on their assigned group to treat hepatoblastoma. Treatment varies by group, including cisplatin monotherapy, combination chemotherapy, and surgery timing either upfront or after chemotherapy cycles. Some participants receive sodium thiosulfate to reduce hearing impairment.
Multiple chemotherapy cycles with visits every 2 to 3 weeks depending on group; surgery visits scheduled after specific chemotherapy cycles or upfront
Follow-up
Duration - Up to 3 years
Participants are monitored after completing treatment to assess event-free survival, hearing, and response to therapy, as well as to record any treatment-related adverse events.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
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Research Team
H
Haishan Ruan, MS
Y
Yujia Tang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial.
David R Freyer, Lu Chen, Mark D Krailo...
https://pubmed.ncbi.nlm.nih.gov/27914822Interventions for cisplatin-induced hearing loss in children and adolescents with cancer.
David R Freyer, Penelope Brock, Kristin Knight...
https://pubmed.ncbi.nlm.nih.gov/31160205Risk-stratified staging in paediatric hepatoblastoma: a unified analysis from the Children's Hepatic tumors International Collaboration.
Rebecka L Meyers, Rudolf Maibach, Eiso Hiyama...
https://pubmed.ncbi.nlm.nih.gov/27884679Platinum-induced ototoxicity in children: a consensus review on mechanisms, predisposition, and protection, including a new International Society of Pediatric Oncology Boston ototoxicity scale.
Penelope R Brock, Kristin R Knight, David R Freyer...
https://pubmed.ncbi.nlm.nih.gov/22547603Dose-dense cisplatin-based chemotherapy and surgery for children with high-risk hepatoblastoma (SIOPEL-4): a prospective, single-arm, feasibility study.
József Zsiros, Laurence Brugieres, Penelope Brock...
https://pubmed.ncbi.nlm.nih.gov/23831416