A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

June 22, 2022 updated by: Eye & ENT Hospital of Fudan University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Margin-negative (R0) resection rate
Time Frame: once the pathology results come out, up to 14 days
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
Time Frame: within 7 days after surgery
The rate of a complete resection based on postoperative imaging findings
within 7 days after surgery
bleeding volume in surgery
Time Frame: From the beginning to the end of the surgery
The hemorrhage volume during surgery
From the beginning to the end of the surgery
Operating time
Time Frame: From the beginning to the end of the surgery
Duration of operating time
From the beginning to the end of the surgery
Surgery-associated restricted mouth opening
Time Frame: at 30 days post surgery
The rate of surgery-associated restricted mouth opening
at 30 days post surgery
Disease-free survival (DFS)
Time Frame: 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
From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years
local recurrence-free survival (LRFS)
Time Frame: From the date of enrollment to local recurrence or death, up to 2 years
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
Time Frame: 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
From the date of enrollment to the end of study, up to2 years
quality of life-(EORTC QLQ) -H&N35
Time Frame: 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
From the date of enrollment to the end of study, up to 2 years.
surgery-associated adverse effect
Time Frame: 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
From the date of surgery to the end of study, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Hongmeng Yu, MD,PhD, Eye&ENT Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rNPC-SA-ETORP-V1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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