Actively Recruiting
A Prospective Clinical Trial of Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients
Led by Sun Yat-sen University · Updated on 2021-06-03
228
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Nasopharyngeal carcinoma (NPC) is most common in eastern Asia, especially among the Cantonese population in Guangdong. Radiotherapy is the standard initial treatment because NPC is sensitive to radiation and located deep in the body. Although radiotherapy has good results, it can cause serious side effects. Surgery is usually for recurrent NPC, but traditional open surgery has many complications and limited success in removing tumors. With advances in surgical techniques, especially the use of electronic endoscopic systems, endoscopic nasopharyngectomy may address these issues. Previous analysis of 9 patients with stage I NPC treated with this surgery showed promising survival rates, suggesting it is a feasible option for early-stage disease. This study compares two treatments for newly diagnosed stage I NPC patients: endoscopic nasopharyngectomy surgery and radical intensity-modulated radiotherapy (IMRT). Endoscopic surgery involves removing the tumor through an endoscope, sometimes using a nasal mucoperiosteal flap to cover defects. The radiotherapy group receives IMRT delivered with a specialized device that targets the tumor precisely. Stage I patients receive only one of these treatments without additional chemotherapy. Participants will be monitored for survival outcomes over 3 years, including overall survival, distant metastasis-free survival, and loco-regional relapse-free survival. Complication rates will also be tracked for 1 year. The study assesses quality of life alongside these outcomes. The total participation period covers treatment and follow-up visits to evaluate patient health and treatment effects under medical supervision.
CONDITIONS
Brief Title
Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated, biopsy-proven World Health Organization (WHO) types II or III nasopharyngeal carcinoma
- Stage I disease according to American Joint Committee on Cancer 7th edition
- Age between 18 and 70 years
- Adequate bone marrow, liver, and kidney function
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- Provided signed informed consent
You will not qualify if you...
- Evidence of relapse or distant metastasis
- History of prior malignancy or previous treatment for nasopharyngeal carcinoma
- Presence of uncontrolled life-threatening diseases
- Investigator judgment that patient is unable to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 to 2 weeks depending on treatment type
Participants receive treatment for Stage I nasopharyngeal carcinoma either through endoscopic nasopharyngectomy surgery or intensity-modulated radiotherapy (IMRT).
1 to 2 visits depending on treatment assignment
Duration - Up to 3 years
Participants are monitored for survival, cancer recurrence, and complications after treatment.
Regular follow-up visits during the 3 years
Trial Site Locations
Total: 5 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
3
The First People's Hospital of Foshan
Guangzhou, Guangdong, China, 528000
Actively Recruiting
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Actively Recruiting
5
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD,Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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