Chemotherapy in Treating Children With Liver Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2000 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Societe Internationale d'Oncologie Pediatrique
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003912
First received: November 1, 1999
Last updated: October 31, 2009
Last verified: December 2000
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective in treating children with liver cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of cisplatin with or without doxorubicin and the effectiveness of combining cisplatin, carboplatin, and doxorubicin in treating children who have liver cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: carboplatin Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: conventional surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tumor response [ Designated as safety issue: No ]
- Complete resection rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Event-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Resection rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 260 |
| Study Start Date: | June 1998 |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven hepatoblastoma or hepatocellular carcinoma
Diagnostic surgical biopsy strongly recommended for all patients and mandatory for the following:
- Children under 6 months of age
- Children over 3 years of age
- Patients with a normal serum alfa-fetoprotein (alfa-FP)
- Compatible imaging and raised serum alfa-FP level mandatory if no biopsy performed
Standard risk disease:
- Tumors involving no more than 3 hepatic sections
- No extrahepatic abdominal disease
- No metastases
High risk disease:
- Tumors involving all 4 hepatic sections AND/OR
- Evidence of extrahepatic metastases or abdominal disease
- Presence or absence of metastatic disease must be documented by chest x-ray and/or lung CT scan
PATIENT CHARACTERISTICS:
Age:
- 16 and under at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- Prior surgery allowed
Contacts and Locations More Information
Additional Information:
Publications:
Brock P, Shafford E, Brugieres L, et al.: Metastatic hepatoblastoma (HB) treated with a dose intensive multiagent chemotherapy regimen, results from the second study of the Childhood Liver Tumour Strategy Group of the International Society of Pediatric Oncology- SIOPEL 2. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1603, 2002.
Perilongo G, Shafford E, Brugieres L, et al.: Cisplatin (CDDP) alone and delayed surgery, an effective treatment for standard risk (SR) hepatoblastoma (HB), the most relevant finding of the SIOPEL2. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1571, 2002.
| ClinicalTrials.gov Identifier: | NCT00003912 History of Changes |
| Other Study ID Numbers: | CDR0000067091, SIOP-SIOPEL-3, EU-98067, UKCCSG-LT-1998-01 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 31, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I childhood liver cancer stage II childhood liver cancer stage III childhood liver cancer stage IV childhood liver cancer |
recurrent childhood liver cancer childhood hepatoblastoma childhood hepatocellular carcinoma |
Additional relevant MeSH terms:
|
Liver Neoplasms Hepatoblastoma Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Adenocarcinoma |
Carcinoma Neoplasms, Glandular and Epithelial Cisplatin Doxorubicin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013