A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432219
• Other study ID #: rNPC-SA-ETORP-V1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: Kun Du, MD,PhD
• Phone: +8618321921664
• Email: dkxuexihao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrence
• Recurrent Nasopharyngeal Carcinoma

Intervention

Procedure:
• endoscopic surgery
endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	bleeding volume in surgery	The hemorrhage volume during surgery	From the beginning to the end of the surgery
Secondary	Operating time	Duration of operating time	From the beginning to the end of the surgery
Secondary	Surgery-associated restricted mouth opening	The rate of surgery-associated restricted mouth opening	at 30 days post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.