Spots Global Cancer Trial Database for Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT

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

Study ID: NCT04215510

Conditions

Recurrent Nasopharyngeal Carcinoma

Interventions

endonasal endoscopic surgery

radiation therapy(IMRT)

Study Description

Brief 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.