Recurrent Nasopharyngeal CarcinomaNCT05432219
A Transoral Retropterygoid Approach to Resect Recurrent Nasopharyngeal Carcinoma
A study testing endoscopic surgery in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University.
Trial summary
This is a a prospective, single-arm, and exploratory study of endoscopic resection of recurrent nasopharyngeal carcinoma via transoral retropterygoid approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- endoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Sufficient organ function.
- With signed informed consent.
- ECOG score 0-2, and general physical condition can tolerate general anesthesia surgery.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- endoscopic surgery
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Transoral Retropterygoid Nasopharyngectomy | Experimental | a novel endoscopic approach to resect nasopharyngeal carcinoma Receives: Procedure: endoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin-negative (R0) resection rate
The rate of the margin-negative resection of the nasopharyngeal carcinoma
Measured: once the pathology results come out, up to 14 days
Secondary outcomes (9)
Rate of a complete resection based on imaging findings
The rate of a complete resection based on postoperative imaging findings
Measured: within 7 days after surgery
bleeding volume in surgery
The hemorrhage volume during surgery
Measured: From the beginning to the end of the surgery
Operating time
Duration of operating time
Measured: From the beginning to the end of the surgery
Surgery-associated restricted mouth opening
The rate of surgery-associated restricted mouth opening
Measured: at 30 days post surgery
Disease-free survival (DFS)
Duration of the disease-free survival after surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the date of surgery to the end of study, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Hongmeng Yu, MD,PhD, Principal investigator, Eye&ENT Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432219
- Sponsor's protocol ID
- rNPC-SA-ETORP-V1
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Transoral Retropterygoid Nasopharyngectomy in Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Exploratory Trial
- ClinicalTrials.gov ID
- NCT05432219
- Acronym / sponsor ID
- rNPC-SA-ETORP-V1
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Transoral Retropterygoid Nasopharyngectomy | Experimental | Procedure: endoscopic surgerya novel endoscopic approach to resect nasopharyngeal carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic surgeryendoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach | Procedure or surgery | Endoscopic Transoral Retropterygoid Nasopharyngectomy |
Primary outcome
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
9 secondary outcomes
Rate of a complete resection based on imaging findings
Time frame: within 7 days after surgery
bleeding volume in surgery
Time frame: From the beginning to the end of the surgery
Operating time
Time frame: From the beginning to the end of the surgery
Surgery-associated restricted mouth opening
Time frame: 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
local recurrence-free survival (LRFS)
Time frame: 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
quality of life-(EORTC QLQ) -H&N35
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongmeng Yu, MD,PhD principal investigator
Eye&ENT Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic surgery in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Du, MD,PhD (+8618321921664, dkxuexihao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin-negative (R0) resection rate (time frame: once the pathology results come out, up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.