Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Intensive Neoadjuvant Chemotherapy in Treating Young Patients Undergoing Surgical Resection for High-Risk Hepatoblastoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | Under 18 | Other | SIOP-SIOPEL-4 EU-20336, CCLG-LT-2004-09, NCT00077389 |
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.
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
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
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
Other
- Not pregnant
- Negative pregnancy test
- No pre-existing clinically relevant bilateral hearing loss
- No other condition that would preclude study participation
Expected Enrollment
57A total of 23-57 patients will be accrued for this study within 2 years.
Outcomes
Primary Outcome(s)Rate of complete remission after completion of study therapy
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
Event-free survival
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
Trial Lead Organizations
University Hospitals of Leicester NHS Trust
 | | | |
| Margaret Childs, Protocol chair | |
| |
| |||
| Registry Information | ||
| ||
| Official Title | Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma | |
| ||
| Trial Start Date | 2004-01-09 | |
| ||
| Registered in ClinicalTrials.gov | NCT00077389 | |
| ||
| Date Submitted to PDQ | 2003-12-22 | |
| ||
| Information Last Verified | 2009-12-17 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Back to Top
