International randomized study to evaluate the addition of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) vs. cisplatin-5-fluorouracil (CF) in the induction treatment of nasopharyngeal carcinoma (NPC) in children and adolescents - ND

• Conditions: Children and adolescents newly diagnosed with NPC with measurable disease T2-T4 any NM, of < o =18 years of age at the time of diagnosis; MedDRA version: 9.1Level: LLTClassification code 10061306Term: Nasopharyngeal cancer

• Registration Number: EUCTR2007-001211-33-IT
• Lead Sponsor: sanofi-aventis recherche & de'veloppement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-06
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Histological diagnosis of nasopharyngeal carcinoma WHO type II or III Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease Ages eligible for study: < or =18 years of age at time of diagnosis. Genders eligible for study: Both All patients and/or their parents or legal guardians must sign a written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with short life expectancy. Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma Performance status (Appendix C) - Patients < o = 16 years of age: Lansky <60%; - Patients > 16 years of age: Karnofsky <60% Creatinine clearance or radioisotope glomerular filtration rate (GFR) <70 mL/min OR Serum creatinine based on age as follows for the calculation of GFR: Greater than 0.8 mg/dL (for patients < = 5 years of age) Greater than 1.0 mg/dL (for patients 6-10 years of age) Greater than 1.2 mg/dL (for patients 11-15 years of age) Greater than 1.5 mg/dL (for patients > 15 years of age) Bilirubin > 1.5 times upper limit of normal (ULN) for age AST or ALT > 2.5 times ULN for age Positive pregnancy test Fertile patients unwilling to use effective contraception Clinical Trial Protocol 24 February 2007 EFC10339 Property of the sanofi-aventis group - strictly confidential Page 29 WW-CLIN-PR007-SD-03 VERSION n03 (22-FEB-2006) Refusal or inability to give informed consents to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified