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Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:
A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma

Clinical Trial Summary

This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.

Clinical Trial Description

Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04215510
Study type Interventional
Source Eye & ENT Hospital of Fudan University
Contact Xiaole Song, MD
Phone +86 15821388769
Email jxfxsxl@163.com
Status Not yet recruiting
Phase Phase 3
Start date March 1, 2021
Completion date March 1, 2027
View Details
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