CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Docetaxel, Cisplatin, 5-FU and Cetuximabdrug
Likely dose
Docetaxel, Cisplatin, 5-FU and Cetuximab 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01326559
NCT01326559Phase 2Completed
CompareCT.gov

Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)

Hong Kong Nasopharyngeal Cancer Study Group Limited·interventional·Posted Mar 31, 2011·Updated Aug 16, 2017

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Cisplatin, 5-FU and Cetuximab for Nasopharyngeal Carcinoma. Completed, enrolled 33 participants across 4 sites.

Detailed Summary

Study Objective: Primary 1\. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT). Secondary 1. To determine the overall response rate. 2. To determine the locoregional and distant control rate 3. To determine the progression-free survival (PFS) 4. To determine the overall survival (OS) 5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma
CountriesChina
CollaboratorsThe University of Hong Kong, Sanofi, Merck Sharp & Dohme LLC, Roche Pharma AG

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2011
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 15.3 years ago

Interventions

Docetaxel, Cisplatin, 5-FU and Cetuximabdrug

Induction phase (Weeks 1-9): Drug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles Drug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles Drug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles Concurrent phase (weeks 10-16): Drug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16) Drug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16) IMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)