A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

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

Detailed Description
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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.

Official Title
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Endoscopic Transoral Retropterygoid Nasopharyngectomy in Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Exploratory Trial

Conditions
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Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Procedure: endoscopic surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Transoral Retropterygoid Nasopharyngectomy<br>a novel endoscopic approach to resect nasopharyngeal carcinoma | Procedure: endoscopic surgery<br>* endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margin-negative (R0) resection rate | The rate of the margin-negative resection of the nasopharyngeal carcinoma | once the pathology results come out, up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of a complete resection based on imaging findings | The rate of a complete resection based on postoperative imaging findings | within 7 days after surgery | 
| bleeding volume in surgery | The hemorrhage volume during surgery | From the beginning to the end of the surgery | 
| Operating time | Duration of operating time | From the beginning to the end of the surgery | 
| Surgery-associated restricted mouth opening | The rate of surgery-associated restricted mouth opening | at 30 days post surgery | 
| Disease-free survival (DFS) | Duration of the disease-free survival after surgery | From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years | 
| local recurrence-free survival (LRFS) | Duration of the local recurrence-free survival (LRFS) after surgery | From the date of enrollment to local recurrence or death, up to 2 years | 
| quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life | 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 | From the date of enrollment to the end of study, up to2 years | 
| quality of life-(EORTC QLQ) -H&N35 | 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 | From the date of enrollment to the end of study, up to 2 years. | 
| surgery-associated adverse effect | 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 | From the date of surgery to the end of study, up to 2 years. |