Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533267
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Endoscopic Surgery vs Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma A Multicenter Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nasopharyngeal carcinoma aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma
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 nasopharyngeal carcinoma was more than 95 However mos patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury which will affect the quality of life of patients to varying degrees For stage Ⅰ nasopharyngeal carcinoma with primary lesion confined to nasopharyngeal mucosa and without regional lymph node metastasis in theory the primary lesion can be removed by minimally invasive surgery without need of preventive treatment of cervical lymph nodes according to the prior study
Based on our previous research results we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 04cm and 06cm respectively and the tumor diameter of nasopharyngeal primary tumor was 15cm This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma
In this study the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor
The patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up The target area and dose of radiotherapy were as follows GTVnx primary lesion of the nasopharynx CTV1 high-risk area and the entire nasopharynx CTV2 low-risk area The recommended intensity-modulated radiotherapy dose is GTVnx6996 Gy33 Fr212 Gy CTV16060 Gy33 Fr182 Gy CTV25412 Gy33 Fr164 Gy
Based on our previous research results we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 04cm and 06cm respectively and the tumor diameter of nasopharyngeal primary tumor was 15cm This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma
In this study the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor
The patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up The target area and dose of radiotherapy were as follows GTVnx primary lesion of the nasopharynx CTV1 high-risk area and the entire nasopharynx CTV2 low-risk area The recommended intensity-modulated radiotherapy dose is GTVnx6996 Gy33 Fr212 Gy CTV16060 Gy33 Fr182 Gy CTV25412 Gy33 Fr164 Gy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None