drugset / Trial / NCT00916097

NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

NCT00916097 ↗

Phase 2 Completed 66 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Primary Objective: To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT. Secondary Objectives: To evaluate: * The radiological response after chemotherapy and radiotherapy * The pathological response after chemotherapy by cavum biopsy To estimate: * The duration of overall response * The time to progression (T.T.P) To analyze: * The overall survival * The safety profile

Timeline

Start
2002-07
Primary completion
2005-11
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 75 mg/m2 Intravenous