drugset / Trial / NCT03017326
Paediatric Hepatic International Tumour Trial
Phase 3
Active not recruiting
450 enrolled
University of Birmingham
Andaluz Health Service · collabBambino Gesù Hospital and Research Institute · collabChildren's University Hospital, Ireland · collabCliniques universitaires Saint-Luc- Université Catholique de Louvain · collabExperimental Cancer Medicine Centres · collabFundació Institut Germans Trias i Pujol · collabGothia Forum - Center for Clinical Trial · collabLudwig-Maximilians - University of Munich · collabMedical University of Gdansk · collabMotol University Hospital · collabNewcastle University · collabPrincess Maxima Center for Pediatric Oncology · collabRennes University Hospital · collabSwiss Pediatric Oncology Group · collabThe Leeds Teaching Hospitals NHS Trust · collabUniversity Hospital Munich · collabUniversity Hospital Tuebingen · collabUniversity Hospital, Bonn · collabUniversity of Kiel · collabUniversity of Oslo · collabUniversity of Padova · collabXenTech, Evry · collab
RandomizedFactorialOpen-labelTreatment
Summary
The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment of children diagnosed with HB. Children with HCC will be included as a separate cohort.
Timeline
- Start
- 2017-08-24
- Primary completion
- 2026-12-31
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 500 mg/m2 | — |
| Comparator | Carboplatin | Small molecule | 800 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Comparator | Etoposide | Small molecule | 400 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Irinotecan | Small molecule | 250 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 100 mg/m2 | — |
| Comparator | Sorafenib | Small molecule | 300 mg/m2 | — |
| Comparator | Vincristine | Small molecule | 3 mg/m2 | — |
| Comparator | Vincristine | Small molecule | 4.5 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 600 mg/m2 | — |