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Clinical Trials/EUCTR2007-001211-33-DE
EUCTR2007-001211-33-DEActive, not recruitingNot Applicable

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

sanofi-aventis recherche & développement0 sites72 target enrollmentStarted: April 24, 2008Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
72
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Similar Trials

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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 NPCChildren 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)
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