Status:
UNKNOWN
Combination Chemotherapy and Thalidomide in Treating Younger Patients Undergoing Surgery For Newly Diagnosed Liver Cancer
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Liver Cancer
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * Determine the event-free and overall survival of younger patients undergoing surgery for newly diagnosed, noncirrhotic hepatocellular carcinoma (HCC) treated with neoadjuvant c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed hepatocellular carcinoma (HCC) family of tumors by percutaneous needle biopsy (unless primary tumor resection is attempted)
- Newly diagnosed disease
- No recurrent disease
- Fibrolamellar and transitional variants
- Noncirrhotic disease
- If suspicious of liver cirrhosis (e.g., abnormal liver function tests and/or positive viral serology and/or radiological evidence) at diagnosis, patient must undergo biopsy of normal liver to exclude liver cirrhosis
- PATIENT CHARACTERISTICS:
- Able to follow the protocol
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Life expectancy at least 3 months
- Glomerular filtration rate ≥ 75-50% of the lower limit of normal for age (≥ 60 mL/min for patients ≥ 2 years old)
- Cardiac ejection fraction ≥ 29% at baseline ECHO
- PRIOR CONCURRENT THERAPY:
- No prior treatment for HCC
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00276705
Start Date
June 1 2005
Last Update
September 17 2013
Active Locations (21)
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1
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
2
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
3
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
4
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ