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Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma Clinical research trials and Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma. Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma  Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
For Condition: childhood hepatoblastoma,stage 4 childhood liver cancer
Status: Not yet recruiting
Sponsor(s): Societe Internationale d'Oncologie Pediatrique ,
Synopsis: 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: Phase II trial to study the effectiveness of neoadjuvant chemotherapy in treating young patients who are undergoing surgical resection for high-riskhepatoblastoma.
Details: OBJECTIVES: Primary - Determine the efficacy and short-term toxicity of intensified neoadjuvant chemotherapy in children with high-risk hepatoblastoma undergoing surgical resection. - Increase the rate of complete surgical resection in these patients by fully implementing liver transplantation as a valid treatment option for tumor removal when partial liver resection or other surgical options remain unfeasible even after extensive preoperative chemotherapy. - Determine, prospectively, the role of this regimen in rendering unresectable tumors resectable in these patients. - Determine the accuracy of initial imaging in predicting the surgical options (after treatment with this regimen) for patients presenting with unresectable disease. Secondary - Determine the overall survival and event-free survival of patients treated with this regimen (with an acceptable overall toxicity). - Determine the toxicity of this regimen in these patients. - Determine the response rate in patients treated with this regimen. - Determine whether response to this regimen, defined by the modified RECIST criteria, can be used for better monitoring of response in these patients. - Determine whether a fall in alpha-fetoprotein during this neoadjuvant regimen can be used as a prognostic factor in these patients. - Determine, prospectively, radiological, surgical, and pathological characteristics of the tumor that might identify possible novel factors that might influence treatment choice and outcome in these patients. OUTLINE: This is an open-label, multicenter study. - Patients receive cisplatin IV over 24 hours on days 1, 8, 15, 29, 36, 43, 57, and 64; and doxorubicin IV over 1 hour OR over 24 hours on days 8, 9, 36, 37, 57, and 58. Patients determined to have resectable disease proceed to surgery. Patients determined to have unresectable disease after neoadjuvant chemotherapy receive additional neoadjuvant chemotherapy comprising carboplatin IV over 1 hour on days 1 and 22 and doxorubicin IV over 1 hour OR over 24 hours on days 1, 2, 3, 22, 23, and 24. Treatment continues in the absence of unacceptable toxicity. - Surgery: Patients determined to have resectable disease undergo complete resection and possibly liver transplantation. - Patients who undergo complete surgical resection receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1 hour OR over 24 hours on days 1 and 2. Treatment repeats every 3 weeks for a total of 3 courses. NOTE: *Patients who received additional neoadjuvant chemotherapy for unresectable disease do not receive adjuvant chemotherapy. Patients are followed every 2-3 months for 2 years, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 23-57 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MargaretChilds, Study Chair, United Kingdom Children's Cancer Study Group
Additional Information:
Study ID Numbers: CDR0000350221; SIOP-SIOPEL-4,EU-20336
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077389
Other Childhood Hepatoblastoma Studies:
1. Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
2. Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
Related Studies:
Other childhood hepatoblastoma Clinical Trials
Other Clinical Trials
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Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
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