A Randomized Multi-institutional Study of Sodium Thiosulfate as Auditory Protection for Children With Hepatoblastoma

STATUS

Recruiting
End date

Sep 30, 2025
participants needed

330
sponsor

Shanghai Children's Medical Center

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Updated on 19 February 2024

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cancer

renal function

glomerular filtration rate

pulmonary function tests

metastatic disease

cancer therapy

hepatoblastoma

Summary

A Phase 3 multi-institutional study for treatment of children with newly diagnosed hepatoblastoma using a modified Paediatric Hepatic International Tumour Trial (PHITT) strategy incorporating a randomized assessment of sodium thiosulfate as auditory protection for children with localized disease, and response adapted therapy for patients with metastatic disease

Description

Primary aims:

Localized Disease: Groups B and C: To evaluate and validate the efficacy of sodium thiosulfate (STS) to reduce the hearing impairment caused by a cisplatin monotherapy in non-metastatic patients without adverse features (localized PRETEXT I-III tumors without positive VPEFR annotation factors) (Group B - treated with cisplatin mono-therapy) or with adverse features (localized PRETEXT I-III tumors with positive VPEFR annotation factors) (Group C - treated with regimen C5VD)
Metastatic Disease: Group D: To determine the 3-year Event-free survival (EFS) in patients with metastatic disease treated with International Society of Paediatric Oncology (SIOPEL 4) induction therapy followed by response adapted consolidation therapy.
To determine the 3-year EFS in patients with HB whose tumor is completely resected at diagnosis (Group A) and either receive no adjuvant chemotherapy (Group A1, completely resected well differentiated fetal (WDF) histology HB) or 2 cycles of standard dose cisplatin monotherapy (Group A2, completely resected non-well differentiated fetal histology HB)

Secondary aims:

To determine any impact of STS on chemotherapy response and survival in children with localized hepatoblastoma
To assess the feasibility of complete resection after 2 cycles of interval compressed lower dose cisplatin monotherapy (80 mg/m2/cycle) in non-metastatic patients and without adverse features
To assess the feasibility of complete resection after 2 cycles of C5VD in non-metastatic patients with adverse features.5. To determine the adherence to PRETEXT and Post-treatment extent of disease (POSTTEXT) based surgical guidelines
To determine the prognostic relevance in HB of a "small cell undifferentiated", tumor component, percentage of tumor necrosis in post chemotherapy specimens, and the relevance of a positive microscopic margin in resected HB specimens.
To determine the concordance between institutional, regional expert panel (prospective) and international expert panel (retrospective) review assessment of PRETEXT and POSTTEXT stage, and correlate with outcome variables.
To prospectively collect patient HB tumor, peripheral blood and urine specimens, for translational biology studies.

Details

Condition	Hepatoblastoma, Hepatoblastoma
Age	18 years and younger
Treatment	Sodium Thiosulfate Injection
Clinical Study Identifier	NCT04478292
Sponsor	Shanghai Children's Medical Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Performance Level Patients must have a performance status corresponding to ECOG scores 0, 1, or 2. Use Karnofsky for patients >16 years of age and Lansky for patients 16 years of age
	Diagnosis Patients must be newly diagnosed with histologically-proven primary pediatric HB
	Emergent Treatment for HB In emergency situation when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy
	Prior Therapy Patients may have had surgical resection of the hepatic malignancy prior to enrollment. All other anti-cancer therapy for the current liver lesion is prohibited
	Organ Function Requirements I) Adequate renal function defined as
	Creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) 70
	mL/min/1.73 m2
	II) Adequate liver function defined as
	Total bilirubin 5 x upper limit of normal (ULN) for age, and Aspartate
	aminotransferase (AST) or Alanine transaminase (ALT) < 10 x upper limit of
	normal (ULN) for age
	III) Adequate pulmonary function defined as
	Normal pulmonary function tests (including DLCO) if there is clinical
	indication for determination (e.g. dyspnea at rest, known requirement for
	supplemental oxygen)
Exclusion Criteria
	Prior chemotherapy or tumor directed therapy expect 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
	Patients with uncontrolled infection
	Patients who previously received a solid organ transplant

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A Randomized Multi-institutional Study of Sodium Thiosulfate as Auditory Protection for Children With Hepatoblastoma