Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bridgewater, New Jersey 08807


Purpose:

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.


Criteria:

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.


NCT ID:

NCT00565448


Primary Contact:

Study Director
Clinical Sciences & Operations
Sanofi-Aventis


Backup Contact:

N/A


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: August 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.