Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
- Conditions
- Liver Cancer
- Registration Number
- NCT00077389
- Lead Sponsor
- University of Leicester
- Brief Summary
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.
- Detailed Description
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.
* Intensified neoadjuvant chemotherapy: 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.
* Adjuvant chemotherapy\*: 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.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 23-57 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 57
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of complete remission after completion of study therapy
- Secondary Outcome Measures
Name Time Method Event-free survival Complete resection rate Response rate to preoperative chemotherapy Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy Overall survival
Trial Locations
- Locations (23)
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Middlesex Hospital
🇬🇧London, England, United Kingdom
Children's Cancer and Leukaemia Group
🇬🇧Leicester, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Institut Gustave Roussy
🇫🇷Villejuif, France
Emma Kinderziekenhuis
🇳🇱Amsterdam, Netherlands
Institute of Child Health at University of Bristol
🇬🇧Bristol, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom