A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Procedure: endoscopic surgery

• Registration Number: NCT05432219
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

This is a a prospective, single-arm, and exploratory study of endoscopic resection of recurrent nasopharyngeal carcinoma via transoral retropterygoid approach.

Detailed Description

The present study explored a novel transoral retropterygoid approach to resect recurrent nasopharyngeal carcinoma, aiming to investigate the effectiveness of this novel approach in the treatment of recurrent nasopharyngeal carcinoma. The primary end point was the margin-negative (R0) resection rate.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
• AJCC rT2-T4 which can be surgically removed.
• No distant metastasis.
• aged 18 or more than 18 years old.
• With or without lymph node metastasis, which can be surgically removed.
• No severe restricted mouth opening, and oral approach eligible.
• Sufficient organ function.
• With signed informed consent.
• ECOG score 0-2, and general physical condition can tolerate general anesthesia surgery.

Exclusion Criteria

• Primary nasopharyngeal carcinoma
• The patient has surgical contraindications: such as severe cardiopulmonary disease and coagulation dysfunction, etc.
• The patient has any situation that may hinder study compliance or the safety during the study period.
• Suffer from uncontrolled disease which could interfere with treatment.
• Uncontrolled active infection.
• Pregnant or breastfeeding women
• There are some other situations that are not suitable for entry into the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic Transoral Retropterygoid Nasopharyngectomy	endoscopic surgery	a novel endoscopic approach to resect nasopharyngeal carcinoma

Primary Outcome Measures

Name	Time	Method
Margin-negative (R0) resection rate	once the pathology results come out, up to 14 days	The rate of the margin-negative resection of the nasopharyngeal carcinoma

Secondary Outcome Measures

Name	Time	Method
Rate of a complete resection based on imaging findings	within 7 days after surgery	The rate of a complete resection based on postoperative imaging findings
bleeding volume in surgery	From the beginning to the end of the surgery	The hemorrhage volume during surgery
local recurrence-free survival (LRFS)	From the date of enrollment to local recurrence or death, up to 2 years	Duration of the local recurrence-free survival (LRFS) after surgery
Operating time	From the beginning to the end of the surgery	Duration of operating time
Surgery-associated restricted mouth opening	at 30 days post surgery	The rate of surgery-associated restricted mouth opening
Disease-free survival (DFS)	From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years	Duration of the disease-free survival after surgery
quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life	From the date of enrollment to the end of study, up to2 years	using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response leve
quality of life-(EORTC QLQ) -H&N35	From the date of enrollment to the end of study, up to 2 years.	using European Organisation for Research and Treatment of Cancer quality of life questionaire（EORTC QLQ）- H\&N35，All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems
surgery-associated adverse effect	From the date of surgery to the end of study, up to 2 years.	Using CTCAE Version5.0 to evaluate related adverse effect Using CTCAE Version5.0 to evaluate related adverse effect Using CTCAE Version5.0 to evaluate related adverse effect Using CTCAE Version 5.0 to evaluate surgery-associated adverse effect