Recurrent Nasopharyngeal Carcinoma
Conditions
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.
Interventions
PROCEDUREendoscopic surgery
endoscopic resection of recurrent nasopharyngeal carcinoma via the transoral retropterygoid nasopharyngectomy approach
Sponsors
Chinese Academy of Medical Sciences
Eye & ENT Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Margin-negative (R0) resection rate | once the pathology results come out, up to 14 days | The rate of the margin-negative resection of the nasopharyngeal carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence-free survival (LRFS) | From the date of enrollment to local recurrence or death, up to 2 years | Duration of the local recurrence-free survival (LRFS) after surgery |
| Disease-free survival (DFS) | 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 |
| Rate of a complete resection based on imaging findings | within 7 days after surgery | The rate of a complete resection based on postoperative imaging findings |
| bleeding volume in surgery | From the beginning to the end of the surgery | The hemorrhage volume during surgery |
| Operating time | From the beginning to the end of the surgery | Duration of operating time |
| Surgery-associated restricted mouth opening | at 30 days post surgery | The rate of surgery-associated restricted mouth opening |
| quality of life-(EORTC QLQ) -C30 version3.0 using European Organisation for Research and Treatment of Cancer quality of life | 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 |
| quality of life-(EORTC QLQ) -H&N35 | 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 |
| surgery-associated adverse effect | 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 |
Contacts
Primary ContactKun Du, MD,PhD
Outcome results
None listed