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Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT).

1.1.1 To reduce therapy associated toxicity for patients with non-metastatic hepatoblastoma (HB) and hepatocellular carcinoma (HCC) without adversely affecting long term outcomes.

1.1.1.1 GroupA:To determinetheevent-freesurvival(EFS)inpatientswithHB
whose tumor is completely resected at diagnosis and either receive no adjuvant chemotherapy (completely resected well differentiated fetal [WDF] histology HB) or 2 cycles of standard dose cisplatin monotherapy (completely resected non-well differentiated fetal histology HB 100 mg/m2/cycle given 3 weeks apart).

1.1.1.2 Group B: To demonstrate that 4 to 6 cycles of interval compressed lower dose cisplatin monotherapy (80 mg/m2/cycle; 320-480 mg/m2 total) is adequate for Low Risk HB.
a. In patients who are resected after 2 cycles of cisplatin monotherapy, to compare EFS following a randomized comparison of 2 versus 4 post-operative cycles of cisplatin monotherapy.
b. In patients whose tumors are deemed unresectable after 2 cycles of cisplatin monotherapy, to determine the proportion of tumors rendered completely resectable by an additional 2 or 4 cycles of chemotherapy.

1.1.1.3 Group C: To compare in a randomized fashion, EFS in patients with Intermediate Risk HB treated with 6 cycles of cisplatin/5- fluorouracil/vincristine/doxorubicin (C5VD) chemotherapy versus 6 cycles of interval compressed cisplatin monotherapy (100 mg/m2/dose).

1.1.1.4 Group E: To determine the EFS in patients with HCC whose tumor is completely resected at diagnosis who receive no adjuvant chemotherapy (completely resected HCC arising in the context of underlying liver disease) or 4 cycles of cisplatin/doxorubicin (PLADO) (completely resected de novo HCC).

1.1.2 To improve the EFS of patients with High Risk HB (Group D) by treating them with interval compressed cisplatin and doxorubicin based induction regimen followed by response-adapted consolidation therapy.

1.1.2.1 Group D1 In patients whose metastatic disease resolves with the
administration of SIOPEL 4 Induction therapy, to determine if the promising pilot results observed in SIOPEL 4 can be validated in a large international study.

1.1.2.2 Group D Arm CE & Arm VI In patients whose metastatic disease does not resolve with the administration of SIOPEL 4 Induction therapy, to determine in a randomized comparison which post induction treatment (irinotecan and vincristine alternating with carboplatin and doxorubicin or carboplatin and etoposide alternating with carboplatin and doxorubicin) results in superior outcomes.

1.1.3 In patients with unresectable/metastatic HCC at diagnosis (Group F), to determine whether the addition of gemcitabine and oxaliplatin (GEMOX + sorafenib) to a cisplatin, doxorubicin and sorafenib backbone improves chemotherapy response, resectability and survival.

Protocol Number: 111806
Phase: Phase II/III
Applicable Disease Sites: Liver
Drugs Involved: CISPLATIN
ETOPOSIDE
OXALIPLATIN
VINCRISTINE
GEMCITABINE
CARBOPLATIN
DOXORUBICIN
IRINOTECAN
Principal Investigator: Scott Moerdler M.D.
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Newark Beth Israel Medical Center
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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