Clinical trial NCT05432219: A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma
Official title: Endoscopic Transoral Retropterygoid Nasopharyngectomy in Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Exploratory Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Nasopharyngeal Carcinoma
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2022-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Margin-negative (R0) resection rate
timeFrame: once the pathology results come out, up to 14 days
Secondary outcomes:
measure: Rate of a complete resection based on imaging findings
timeFrame: within 7 days after surgery
measure: bleeding volume in surgery
timeFrame: From the beginning to the end of the surgery
measure: Operating time
timeFrame: From the beginning to the end of the surgery
measure: Surgery-associated restricted mouth opening
timeFrame: at 30 days post surgery
measure: Disease-free survival (DFS)
timeFrame: From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years
measure: local recurrence-free survival (LRFS)
timeFrame: From the date of enrollment to local recurrence or death, up to 2 years
measure: quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life
timeFrame: From the date of enrollment to the end of study, up to2 years
measure: quality of life-(EORTC QLQ) -H&N35
timeFrame: From the date of enrollment to the end of study, up to 2 years.
measure: surgery-associated adverse effect
timeFrame: From the date of surgery to the end of study, up to 2 years.
Other outcomes:
Locations:
Study officials:
affiliation: Eye&ENT Hospital, Fudan University
name: Hongmeng Yu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: