Status:
COMPLETED
Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Childhood Liver Tumours Strategy Group - SIOPEL
Conditions:
Liver Cancer
Ototoxicity
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs...
Detailed Description
OBJECTIVES: Primary * To assess the efficacy of sodium thiosulfate (STS) to reduce the hearing impairment caused by cisplatin chemotherapy. Secondary * To carefully monitor any potential impact of...
Eligibility Criteria
Inclusion
- Inclusion Histologically confirmed newly diagnosed hepatoblastoma
- Standard risk hepatoblastoma (Pretext I,II,III)
- Age ≤ 18 years and \> 1 month
- Written informed consent and national/local ethics committee and regulatory approval
- Centre/country willing and able to organise audiometry at the minimum required quality standard and to provide the contact details of the Consultant Audiologist or Ear Nose and Throat Surgeon who will take the responsibility for seeing that this is done
- Ability to comply with requirements for submission of material for central review
- For females of child-bearing potential, a negative pregnancy test prior to study treatment is required.
- Any patient who is of reproductive age should agree to use adequate contraception for the duration of the trial.
- Exclusion:
- High risk hepatoblastoma
- Hepatocellular carcinoma
- Treatment starting more than 15 days from written biopsy report
- Abnormal renal function
- Any previous chemotherapy
- Recurrent disease
- Previous hypersensitivity to STS
- Patient unable to follow the protocol for any reason
Exclusion
Key Trial Info
Start Date :
December 15 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00652132
Start Date
December 15 2007
End Date
February 28 2018
Last Update
May 29 2018
Active Locations (16)
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1
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
2
Bristol Royal Hospital for Childre
Bristol, England, United Kingdom, BS2 8AE
3
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
4
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ