NCT03353467

Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

A Prospective Clinical Trial of Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC. With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above. In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible. This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.

Conditions

• Nasopharyngeal Carcinoma
• Endoscopic Surgery
• Primary Napharyngeal Carcinama
• Stage I Nasopharyngeal Cancer

Interventions

Type	Name	Description
PROCEDURE	Endoscopic surgery	Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
RADIATION	Intensity-modulated radiotherapy	All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.

Timeline

• Start date: 2017-10-01
• Primary completion: 2025-10-01
• Completion: 2028-10-01
• First posted: 2017-11-27
• Last updated: 2021-06-03

Locations

5 sites across 1 country: China