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ACTIVE NOT RECRUITING
NCT02460887
PHASE3

The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).

Official title: A Randomized Trial Comparing Induction Gemcitabine and Cisplatin Plus Intensity-modulated Radiotherapy with Concurrent Cisplatin Plus Intensity-modulated Radiotherapy in Patients with Locoregionally Advanced Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2015-06

Completion Date

2025-04

Last Updated

2024-12-03

Healthy Volunteers

No

Interventions

DRUG

Gemcitabine

Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.

DRUG

cisplatin

Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.

DRUG

cisplatin

Active Comparator arm: Patients receive weekly cisplatin 40 mg/m² up to 7cycles during IMRT.

RADIATION

Intensity-modulated Radiotherapy

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China