NCT04215510

Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	endonasal endoscopic surgery	143 patients will undergo endonasal endoscopic surgery
RADIATION	radiation therapy(IMRT)	143 patients will undergo radiation therapy.

Timeline

• Start date: 2021-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2020-01-02
• Last updated: 2021-02-23

Locations

3 sites across 1 country: China