CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 468 target
Drug / intervention
gemcitabine and cisplatin +3 moredrug
Likely dose
gemcitabine and cisplatin 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03840421
NCT03840421Phase 3ActiveOn TrackUpdated 17mo ago
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GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial

Sun Yat-sen University·interventional·Posted Feb 15, 2019·Updated Jan 13, 2025

In Brief

A Phase 3 clinical trial evaluating gemcitabine and cisplatin, cisplatin and fluorouracil, and 2 other interventions for Nasopharyngeal Carcinoma and 3 related conditions. Active but no longer recruiting, targeting 468 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasm
CountriesChina
CollaboratorsFirst Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, China, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Timeline

Phase 3Active
20192020202120222023202420252026202720282029
First PostedFeb 15, 2019
Enrollment StartApr 3, 2019
Primary CompletionAug 31, 2026
Study CompletionDec 31, 2028
TodayJul 1, 2026
Enrollment to primary: 7.4 yearsPosted 7.4 years agoPrimary completion in 2 months

Interventions

gemcitabine and cisplatindrug

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

cisplatin and fluorouracildrug

Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

IMRTradiation

Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor

cisplatindrug

IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.