A clinical trial to study the effect of Docetaxel when added to standard treatment (Cisplatin and 5-FluroUracil) in Nasopharyngeal Carcinoma in children and adolescents.
- Conditions
- -C10 Malignant neoplasm of oropharynxMalignant neoplasm of oropharynxC10
- Registration Number
- PER-045-08
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
• New diagnosis of the disease NPC Stage niB-IV with measurable disease
• Age eligible for the study: <18 years of age at the time of diagnosis
• Genders eligible for the study: Both
• All patients and / or their parents or legal guardians must sign a written informed consent
• Patients with low life expectancy.
• Chemotherapy or radiotherapy prior to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
• Performance status: Patients <16 years of age: Lansky <60%; Patients> 16 years of age: Kamofsky <60%
• Creatinine excretion or glomerular filtration rate of the radioisotope (GFR) <70 mL / min
• Bilirubin> 1.5 times the upper limit of normal (ULN) by age
• AST or ALT> 2.5 times ULN per age
• Positive pregnancy test
• Fertile patients without willingness to use effective contraceptives
• Denial or inability to give informed consent to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method