CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
docetaxel +2 moredrug
Likely dose
Not stated in 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/NCT00565448
NCT00565448Phase 2Completed
CompareCT.gov

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

Sanofi·interventional·Posted Nov 30, 2007·Updated Jul 30, 2015

In Brief

A Phase 2 clinical trial evaluating docetaxel, cisplatin, and 1 other intervention for Nasopharyngeal Neoplasms and Carcinoma. Completed, enrolled 75 participants across 26 sites in 14 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Neoplasms, Carcinoma
CountriesAlgeria, Brazil, China, France, India, Indonesia, Italy, Mexico, Morocco, Philippines, South Korea, Thailand, Tunisia, Turkey (Türkiye)
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 30, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2009
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.6 years ago

Interventions

docetaxeldrug

Pharmaceutical form:solution for infusion Route of administration:intravenous

cisplatindrug

Pharmaceutical form:solution for infusion Route of administration:intravenous

5-fluorouracildrug

Pharmaceutical form:solution for infusion Route of administration:intravenous