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 - Docetaxel Pediatric study in NPC

• Conditions: Children and adolescents newly diagnosed with NPC Stage IIB-IV with measurable disease, of >1 month to =21 years of age at the time of diagnosis.; MedDRA version: 14.1Level: LLTClassification code 10028793Term: Nasopharyngeal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-001211-33-Outside-EU/EEA
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 72

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.
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

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 (Appendix C)
- Patients = 16 years of age: Lansky <60%
- Patients > 16 years of age: Karnofsky <60%
4. Creatinine clearance or radioisotope glomerular filtration rate (GFR) <70 mL/min (13) 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)
5. Bilirubin > 1.5 times upper limit of normal (ULN) for age (13)
6. AST or ALT > 2.5 times ULN for age (13)
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

Study & Design

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