Chemotherapy in Treating Children With Liver Cancer

NCT00003912 | Completed Phase 3

• 4 other identifiers: CDR0000067091SIOP-SIOPEL-3EU-98067UKCCSG-LT-1998-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Tumor response

• Complete resection rate

• Overall survival

• Event-free survival

• Toxicity

• Response rate

• Resection rate

Interventions

carboplatin DRUG

cisplatin DRUG

doxorubicin hydrochloride DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Societe Internationale d'Oncologie Pediatrique: lead

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Perilongo G, Shafford E, Plaschkes J; Liver Tumour Study Group of the International Society of Paediatric Oncology. SIOPEL trials using preoperative chemotherapy in hepatoblastoma. Lancet Oncol. 2000 Oct;1:94-100. doi: 10.1016/s1470-2045(00)00018-8.

  PMID: 11905674 BACKGROUND

• 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. doi: 10.1056/NEJMoa0810613.

  PMID: 19846851 RESULT

• Weeda VB, Murawski M, McCabe AJ, Maibach R, Brugieres L, Roebuck D, Fabre M, Zimmermann A, Otte JB, Sullivan M, Perilongo G, Childs M, Brock P, Zsiros J, Plaschkes J, Czauderna P, Aronson DC. Fibrolamellar variant of hepatocellular carcinoma does not have a better survival than conventional hepatocellular carcinoma--results and treatment recommendations from the Childhood Liver Tumour Strategy Group (SIOPEL) experience. Eur J Cancer. 2013 Aug;49(12):2698-704. doi: 10.1016/j.ejca.2013.04.012. Epub 2013 May 15.

  PMID: 23683550 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Hepatoblastoma

Interventions

Carboplatin; Cisplatin; Doxorubicin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Giorgio Perilongo, MD

  Azienda Ospedaliera di Padova

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: June 1, 1998
• Study Completion: October 1, 2009
• Last Updated: December 4, 2013

Record last verified: 2000-12

Locations

IT (1)