Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
Recruiting now · Not applicable
Conditions studied: Nasopharyngeal Carcinoma, Intensity Modulated Radiotherapy, Surgery
In brief
The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.
Key facts
- Study ID
- NCT06533267
- Run by
- Sun Yat-sen University
- People needed
- 442
- Starts
- 2024-03-25
- Expected to finish
- 2034-03-25
- Last updated by the study team
- 2024-08-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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