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A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Recurrent Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endoscopic surgery
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Endoscopic Transoral Retropterygoid Nasopharyngectomy

    Arm Description

    a novel endoscopic approach to resect nasopharyngeal carcinoma

    Outcomes

    Primary Outcome Measures

    Margin-negative (R0) resection rate
    The rate of the margin-negative resection of the nasopharyngeal carcinoma

    Secondary Outcome Measures

    Rate of a complete resection based on imaging findings
    The rate of a complete resection based on postoperative imaging findings
    bleeding volume in surgery
    The hemorrhage volume during surgery
    Operating time
    Duration of operating time
    Surgery-associated restricted mouth opening
    The rate of surgery-associated restricted mouth opening
    Disease-free survival (DFS)
    Duration of the disease-free survival after surgery
    local recurrence-free survival (LRFS)
    Duration of the local recurrence-free survival (LRFS) after surgery
    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
    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
    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

    Full Information

    First Posted
    June 16, 2022
    Last Updated
    June 22, 2022
    Sponsor
    Eye & ENT Hospital of Fudan University
    Collaborators
    Chinese Academy of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05432219
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eye & ENT Hospital of Fudan University
    Collaborators
    Chinese Academy of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Nasopharyngeal Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endoscopic Transoral Retropterygoid Nasopharyngectomy
    Arm Type
    Experimental
    Arm Description
    a novel endoscopic approach to resect nasopharyngeal carcinoma
    Intervention Type
    Procedure
    Intervention Name(s)
    endoscopic surgery
    Intervention Description
    endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach
    Primary Outcome Measure Information:
    Title
    Margin-negative (R0) resection rate
    Description
    The rate of the margin-negative resection of the nasopharyngeal carcinoma
    Time Frame
    once the pathology results come out, up to 14 days
    Secondary Outcome Measure Information:
    Title
    Rate of a complete resection based on imaging findings
    Description
    The rate of a complete resection based on postoperative imaging findings
    Time Frame
    within 7 days after surgery
    Title
    bleeding volume in surgery
    Description
    The hemorrhage volume during surgery
    Time Frame
    From the beginning to the end of the surgery
    Title
    Operating time
    Description
    Duration of operating time
    Time Frame
    From the beginning to the end of the surgery
    Title
    Surgery-associated restricted mouth opening
    Description
    The rate of surgery-associated restricted mouth opening
    Time Frame
    at 30 days post surgery
    Title
    Disease-free survival (DFS)
    Description
    Duration of the disease-free survival after surgery
    Time Frame
    From the date of enrollment to relapse or metastasis or death from any cause, up to 2 years
    Title
    local recurrence-free survival (LRFS)
    Description
    Duration of the local recurrence-free survival (LRFS) after surgery
    Time Frame
    From the date of enrollment to local recurrence or death, up to 2 years
    Title
    quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life
    Description
    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
    Time Frame
    From the date of enrollment to the end of study, up to2 years
    Title
    quality of life-(EORTC QLQ) -H&N35
    Description
    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
    Time Frame
    From the date of enrollment to the end of study, up to 2 years.
    Title
    surgery-associated adverse effect
    Description
    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
    Time Frame
    From the date of surgery to the end of study, up to 2 years.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kun Du, MD,PhD
    Phone
    +8618321921664
    Email
    dkxuexihao@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hongmeng Yu, MD,PhD
    Organizational Affiliation
    Eye&ENT Hospital, Fudan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma

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