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COMPLETED
NCT02633202
PHASE3

Concurrent Chemotherapy for the Intermediate Risk Nasopharyngeal Carcinoma In Intensity-modulated Radiotherapy Era

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above,the investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43

Official title: Prospective Non-inferior Clinical Trial Comparing Concurrent Chemoradiotherapy or Radiotherapy Alone in Patients With Intermediate Risk Nasopharyngeal Carcinoma in Intensity-modulated Radiotherapy Era

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

338

Start Date

2015-11

Completion Date

2021-10-11

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

RADIATION

IMRT

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.20 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

DRUG

Cisplatin

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China