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------------------------------------------Estudio aleatorizado internacional para evaluar la suma de docetaxel a la combinación de cisplatino-5-fluoruracilo (TCF) vs. cisplatino-5-fluorouracilo (CF) en el tratamiento de inducción del carcinoma nasofaríngeo (CNF) en niños y adolescentes. - Docetaxel Pediatric study in NPC
- Conditions
- Children and adolescents newly diagnosed with NPC with measurable disease T2-T4 any NM, of <18 years of age at the time of diagnosis.----------Niños y adolescentes recien diagnosticados con CNF con lesiones medibles T2-T4 cualquier NM, de <18 años en el momento del diagnóstico.MedDRA version: 9.1Level: LLTClassification code 10028793Term: Nasopharyngeal carcinoma
- Registration Number
- EUCTR2007-001211-33-ES
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
• 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: <=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) no
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
• 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 = 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
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• 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method