Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
The Fifth Affiliated Hospital of Sun Yat-sen University
RECRUITING
Zhuhai
Contact Information
Primary
Ming-Yuan Chen, MD,PhD
chmingy@email.sysu.edu.cn
+8613903052650
Backup
Youping Liu, PhD
liuyp78@email.sysu.edu.cn
+86137517763276
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2034-03-25
Participants
Target number of participants: 442
Treatments
Experimental: Surgery plus close follow-up
Surgery:~Endoscopic Nasopharyngectomy: Radical resection of the primary lesion using nasal endoscopy.
Active_comparator: Intensity modulated radiotherapy
Radiotherapy:~Intensity-modulated Radiotherapy:~GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy
Related Therapeutic Areas
Sponsors
Collaborators: Nanfang Hospital, Southern Medical University, Fifth Affiliated Hospital of Guangzhou Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University, Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital), First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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