Expired Study
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Bridgewater, New Jersey 08807


The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC). The secondary objectives are to determine: - the safety of TCF in comparison to CF after induction treatment of NPC, - the pharmacokinetics of docetaxel when added to CF, - the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.

Study summary:

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.



Primary Contact:

Study Director
Clinical Sciences & Operations

Backup Contact:


Location Contact:

Bridgewater, New Jersey 08807
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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