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

First Received on November 1, 1999. Last Updated on October 31, 2009 History of Changes

Sponsor:	Societe Internationale d'Oncologie Pediatrique
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003912

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Liver Tumour Studies - Hepatoblastoma and Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Carboplatin

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003912

Locations

Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128

Sponsors and Collaborators

Societe Internationale d'Oncologie Pediatrique

Investigators

Study Chair:

Giorgio Perilongo, MD

Azienda Ospedaliera di Padova

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Perilongo G, Maibach R, Shafford E, Brugieres L, Brock P, Morland B, de Camargo B, Zsiros J, Roebuck D, Zimmermann A, Aronson D, Childs M, Widing E, Laithier V, Plaschkes J, Pritchard J, Scopinaro M, MacKinlay G, Czauderna P. Cisplatin versus cisplatin plus doxorubicin for standard-risk hepatoblastoma. N Engl J Med. 2009 Oct 22;361(17):1662-70.

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.

Perilongo G, Shafford E, Plaschkes J. SIOPEL trials using preoperative chemotherapy in hepatoblastoma. Lancet Oncol. 2000 Oct;1:94-100. Review.

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 February 09, 2012