Status:
RECRUITING
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Fifth Affiliated Hospital, Sun Yat-Sen University
Fifth Affiliated Hospital of Guangzhou Medical University
Conditions:
Nasopharyngeal Carcinoma
Intensity Modulated Radiotherapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 n...
Detailed Description
The newly diagnosed non-metastatic nasopharyngeal carcinoma has shown satisfactory therapeutic effect under the intensity modulated radiation. The 5-year survival rate of the newly diagnosed Ⅰ nasopha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2034
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT06533267
Start Date
March 25 2024
End Date
March 25 2034
Last Update
August 1 2024
Active Locations (1)
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1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000