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
1 Month
21 Years
Both
Nasopharyngeal Neoplasms, Carcinoma
Trial Information
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
Planned treatment duration:
- induction period: 9 weeks of induction treatment
- consolidation period: 9 weeks of chemoradiation treatment.
The consolidation treatment was the same for all patients: Radiation Therapy for 7-8 weeks
and 3 cycles of cisplatin 100 mg/m2 every 21 days.
Inclusion Criteria:
- Histological diagnosis of nasopharyngeal carcinoma World Health Organization (WHO)
type II or III
- Children and adolescents newly diagnosed with Stage IIB-IV NPC with measurable
disease, who are >1 month to ≤21 years of age at the time of diagnosis. In France,
patients must be ≥1 year to ≤21 years of age at the time of diagnosis
Exclusion Criteria:
- Patients with short life expectancy
- Prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of
nasopharyngeal carcinoma
- Inadequate renal function evidenced by unacceptable laboratory results
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete Response (CR)
Outcome Description:
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
Outcome Time Frame:
after the completion of the induction treatment (up to 9 weeks)
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
United States: Food and Drug Administration
Study ID:
EFC10339
NCT ID:
NCT00565448
Start Date:
November 2007
Completion Date:
January 2012
Related Keywords:
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal carcinoma
- Neoplasms
- Carcinoma
- Nasopharyngeal Neoplasms
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