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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Previously untreated, biopsy-proven World Health Organization (WHO) types II or III NPC; Stage I disease (American Joint Committee on Cancer 7th edition); Between 18 and 70 years old; Adequate bone marrow, liver and renal function; Satisfactory performance status: a score of 0 or 1 using the Eastern Cooperative Oncology Group System; Patients provided signed informed consent.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
The First People's Hospital of Foshan
RECRUITING
Guangzhou
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Zhongshan People's Hospital
RECRUITING
Zhongshan
Contact Information
Primary
Ming-Yuan Chen, MD,Ph.D
chmingy@mail.sysu.edu.cn
86-13903052650
Time Frame
Start Date: 2017-10-01
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 228
Treatments
Experimental: Group in endoscopic surgery
Stage I patients were only treated with endoscopic surgery without additional chemotherapy. Endoscopic nasopharyngectomy included endoscopic resection , with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
Active_comparator: Group in IMRT
Stage I patients were only treated with radical intensity-modulated radiotherapy without additional chemotherapy. IMRT was delivered with a dynamic multileaf intensity-modulating collimator (NOMOS, Sewickley, PA) by a slice-by-slice arc rotation approach.
Related Therapeutic Areas
Sponsors
Collaborators: People's Hospital of Guangxi Zhuang Autonomous Region, First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov