CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 562 target
Drug / intervention
gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil +2 moredrug
Likely dose
gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil 1000 mgfrom 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/NCT04414566
NCT04414566Phase 3Unknown
CompareCT.gov

Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

West China Hospital·interventional·Posted Jun 4, 2020·Updated Jun 4, 2020

In Brief

A Phase 3 clinical trial evaluating gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil, IMRT, and 1 other intervention for Nasopharyngeal Carcinoma. Targeting 562 participants across 1 site.

Detailed Summary

The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 3UnknownOverdue
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartJun 1, 2020
Primary CompletionMay 30, 2022
Study CompletionMay 30, 2025
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 6.1 years ago

Interventions

gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracildrug

Patients receive GP gemcitabine (1000 mg/m\^2 d1,8) and cisplatin (80mg/m\^2 d1) or TPF docetaxel (60mg/m\^2 on day 1), cisplatin (60mg/m\^2 on day 1) and fluorouracil (600mg/m\^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

IMRTradiation

Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

IMRT and concurrent cisplatinradiation

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m\^2 every 3 weeks for 3 cycles.