Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Endoscopic nasopharyngectomy followed close follow-up
- Intensity-modulated Radiotherapy
Treatment groups
442 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sun Yat-sen University
Lead sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Fifth Affiliated Hospital of Guangzhou Medical University
Collaborator
Huazhong University of Science and Technology Union Shenzhen Hospital
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First People's Hospital of Foshan
Collaborator
Zhongshan People's Hospital, Guangdong, China
Collaborator
Source ClinicalTrials.gov