Status:
UNKNOWN
A Randomized Controlled Clinical Trial of Surgery Versus Conservative Treatment for Mild and Moderate-grade Nasopharyngeal Necrosis
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma, Postradiation, Necrosis, Endoscopy Surgery, Conservative Treatment
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Post radiation nasopharyngeal necrosis is a relatively special radiotherapy sequelae after radiotherapy for nasopharyngeal carcinoma. According to the degree of its development, it can be roughly divi...
Eligibility Criteria
Inclusion
- Received radical radiotherapy for the nasopharynx;
- For patients with early-stage and mid-stage nasopharyngeal necrosis diagnosed for the first time by clinical symptoms, imaging examinations and pathology. The lesions are limited to the superficial tissue of the nasopharynx and the deep tissue of each wall of the nasopharynx, regardless of the exposure of internal carotid artery invasion(ICA). For those patients with ICA exposure, vascular pretreatment (vascular embolization or bypass surgery) would be performed and reassess after 2-4 weeks of vascular treatment.
- The patient has signed the informed notice and is willing and able to comply with the study plan visits, treatment plans, laboratory tests and other study procedures.
Exclusion
- Karnofsky score ≤ 70 points or Zubrod score \> 2 points;
- Patients with severe medical complications, insufficiency of important organs (heart, lung, liver, kidney) or neuropsychiatric disorders at the time of diagnosis.
- Patients with pathologically confirmed local recurrence.
- Cases who have received local nasal cavity and nasopharyngeal surgery in the past.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Other patients who are considered unsuitable for inclusion by the treating physician.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05228093
Start Date
November 1 2021
End Date
October 30 2024
Last Update
February 8 2022
Active Locations (4)
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1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
3
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510700
4
The First Hospital of Nanchang
Nanchang, Jiangxi, China, 330000