Comparing endoscopic surgery and radiotherapy for early-stage nasopharyngeal cancer
Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.
This study is testing whether endoscopic surgery or radiotherapy works better for people with early-stage nasopharyngeal cancer and how each treatment affects their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 442 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06533267 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the survival rates and adverse reactions between endoscopic surgery and intensity-modulated radiotherapy in patients with newly diagnosed stage I nasopharyngeal carcinoma. The study focuses on patients whose tumors are confined to the nasopharyngeal mucosa and have no regional lymph node metastasis. Participants in the experimental group will undergo minimally invasive endoscopic surgery, while the control group will receive conventional radiotherapy. The trial will closely monitor patients for tumor recurrence and metastasis following treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with newly diagnosed, non-metastatic stage I nasopharyngeal carcinoma who meet specific tumor size and lymph node criteria.
Not a fit: Patients with larger tumors, recurrent disease, or significant vascular malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option with fewer side effects for patients with early-stage nasopharyngeal carcinoma.
How similar studies have performed: Previous studies have shown promising results for minimally invasive surgical approaches in similar conditions, suggesting potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Karnofsky score \>70. * Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically. * According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I. * The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative. * Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol. Exclusion Criteria: * MRI showed that the primary tumor diameter \>1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation. * Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy. * Suffering severe organ dysfunction or physical disorder which could not tolerate operation or radiotherapy. * Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
Where this trial is running
Zhuhai, Guangdong
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ming-Yuan Chen, MD,PhD — Sun Yat-sen University
- Study coordinator: Ming-Yuan Chen, MD,PhD
- Email: chmingy@email.sysu.edu.cn
- Phone: +8613903052650
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.