CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 442 target
Drug / intervention
Endoscopic nasopharyngectomy followed close follow-up +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06533267
NCT06533267N/ARecruitingOn TrackUpdated 22mo ago

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

Sun Yat-sen University·interventional·Posted Aug 1, 2024·Updated Aug 1, 2024

In Brief

A clinical study evaluating Endoscopic nasopharyngectomy followed close follow-up and Intensity-modulated Radiotherapy for Nasopharyngeal Carcinoma and 2 related conditions. Currently recruiting, targeting 442 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ARecruiting
20242025202620272028202920302031203220332034
First PostedAug 1, 2024
Enrollment StartMar 25, 2024
Primary CompletionMar 25, 2034
TodayJul 1, 2026
Enrollment to primary: 10 yearsPosted 1.9 years agoPrimary completion in 7.7 years

Interventions

Endoscopic nasopharyngectomy followed close follow-upprocedure

Radical resection of primary lesion using nasal endoscopy. After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.

Intensity-modulated Radiotherapyradiation

GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy. After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.