Health Condition 1: C119- Malignant neoplasm of nasopharynx,unspecified Health Condition 2: null- Nasopharyngeal Carcinoma in children and adolescents.
Conditions
Interventions
Intervention1: Docetaxel: 75 mg/m2, Intravenous, on Day 1, every 3 weeks (3 cycles)
Control Intervention1: Cisplatin: 75 mg/m2, Intravenous, over 6 hours, on Day 1, every 3 weeks (3 cycles)
Sponsors
Sanofi Synthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological confirmed nasopharyngeal carcinoma, subtypes WHO type II (non-keratinizing carcinoma) or III (undifferentiated carcinoma including lymphoepitheliomas) 2. Newly diagnosed disease NPC Stage IIB-IV disease with measurable disease. 3. Ages eligible for study: >1 month to ≤21 years of age at time of diagnosis. 4. Genders eligible for study: Both 5. All patients and/or their parents or legal guardians must sign a written informed consent and assent.
Exclusion criteria
Exclusion criteria: 1. Patients with short (less than 12 weeks) of life expectancy. 2. Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma 3. Performance status: &#8722; Patients &#8804;16 years of age: Lansky <60% &#8722; Patients >16 years of age: Karnofsky <60% 4. Creatinine clearance or radioisotope glomerular filtration rate (GFR) <70 mL/min OR Serum creatinine based on age as follows for the calculation of GFR to : &#8722; Greater than 0.8 mg/dL (for patients &#8804;5 years of age) &#8722; Greater than 1.0 mg/dL (for patients 6-10 years of age) &#8722; Greater than 1.2 mg/dL (for patients 11-15 years of age) &#8722; Greater than 1.5 mg/dL (for patients >15 years of age) 5. Bilirubin >1.5 times upper limit of normal (ULN) for age 6. AST or ALT >2.5 times ULN for age 7. Hypersensitivity to one of the drugs or their excipients. 8. Pregnant or breast feeding females 9. Females of child bearing potential who are unwilling or unable to be tested for pregnancy 10. Females of child bearing potential who are unwilling or unable to use effective contraception 11. Refusal or inability to give informed consents to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point: Complete response (CR) rate following the Induction treatment and prior to the radiation treatment. Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points: 1. Overall safety and efficacy of docetaxel in combination with CF. 2. Overall response on completion of Radiotherapy treatment. 3. Role of EBV and the predictive value of the determination of EBV-DNA in peripheral blood. 4. Overall survival comparison between arms.Timepoint: 3 years | — |
Countries
India, Indonesia, Morocco, South Africa, Thailand, Turkey
Contacts
Public ContactMrs Gayatri Jaiswal
Sanofi Synthelabo India Limited
Outcome results
None listed