Endoscopic surgery for early-stage nasopharyngeal cancer
A Prospective Clinical Trial of Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients
This study tests if a new type of endoscopic surgery, combined with targeted radiation, can help people with early-stage nasopharyngeal cancer have better outcomes and fewer side effects than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT03353467 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of endoscopic nasopharyngectomy as a treatment for patients with newly diagnosed Stage I nasopharyngeal carcinoma. The approach aims to improve surgical outcomes by minimizing complications associated with traditional open surgery, leveraging advancements in endoscopic techniques. Patients will receive endoscopic surgery combined with intensity-modulated radiotherapy, which is designed to enhance treatment efficacy while reducing adverse effects. The study focuses on patients who have not received prior treatment and meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with biopsy-proven Stage I nasopharyngeal carcinoma who have not received prior treatment.
Not a fit: Patients with evidence of relapse, distant metastasis, or uncontrolled life-threatening diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option with fewer complications for patients with early-stage nasopharyngeal carcinoma.
How similar studies have performed: While traditional surgery has been used for recurrent cases, this endoscopic approach is relatively novel and has not been extensively tested in primary nasopharyngeal carcinoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Evidence of relapse or distant metastasis; History of prior malignancy or previous treatment for NPC; The presence of uncontrolled life-threatening diseases; The investigator considered the patient unable to complete the study.
Where this trial is running
Guangzhou, Guangdong and 4 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
- The First People's Hospital of Foshan — Guangzhou, Guangdong, China (Recruiting)
- Zhongshan People's Hospital — Zhongshan, Guangdong, China (Recruiting)
- The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Recruiting)
Study contacts
- Study coordinator: Ming-Yuan Chen, MD,Ph.D
- Email: chmingy@mail.sysu.edu.cn
- Phone: 86-13903052650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.