Comparing endoscopic surgery and radiotherapy for early-stage nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.