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Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
Not Recruiting
Trial ID: NCT00077389
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma.
Official Title
Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma
Stanford Investigator(s)
Eligibility
DISEASE CHARACTERISTICS:
* Histologically confirmed hepatoblastoma
* High-risk disease, meeting criteria for at least 1 of the following:
* Tumor involving all 4 hepatic sections
* Evidence of abdominal extrahepatic disease
* Presence of metastases
* Alpha-fetoprotein \< 100 ng/mL at diagnosis
* Must have had a prior diagnostic biopsy within the past 15 days
* No recurrent disease
PATIENT CHARACTERISTICS:
Age
* Under 18
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* AST and/or ALT ≤ 3 times normal
Renal
* Glomerular filtration rate ≥ 60 mL/min
Cardiovascular
* Shortening fraction ≥ 29% OR
* Ejection fraction ≥ 40%
Other
* Not pregnant
* Negative pregnancy test
* No pre-existing clinically relevant bilateral hearing loss
* No other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior therapy for hepatoblastoma
Intervention(s):
drug: carboplatin
drug: cisplatin
drug: doxorubicin hydrochloride
procedure: adjuvant therapy
procedure: conventional surgery
procedure: neoadjuvant therapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535