Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This study aims at exploring whether plasma radiofrequency ablation at low temperature is associated with better survival outcome in localized recurrent nasopharyngeal carcinoma by conducting a randomized controlled trial of plasma radiofrequency ablation at low temperature versus electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma. If the hypothesis is confirmed, it is expected to provide a convenient choice for the surgical treatment of localized recurrent nasopharyngeal carcinoma.

Official Title
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A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma.

Conditions
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Surgery, Recurrent Nasopharyngeal Carcinoma

Intervention / Treatment
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* Procedure: Electrocautery block resection
* Procedure: Plasma radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 6 months disease free interval (defined as duration between the initial course of radiotherapy and recurrence) Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma. Resectable recurrent nasopharyngeal carcinoma: A) recurrent T1N0M0 according to the American Joint Committee on Cancer (AJCC) 8th staging B) recurrent T2N0M0(the tumor was confined to the surface of the parapharyngeal space and was more than 0.5cm away from the internal carotid artery) according to the American Joint Committee on Cancer (AJCC) 8th staging Age: 18-70 years old. Subjects must sign an informed consent form. Exclusion Criteria: Karnofsky score (KPS)≤70. Has known Subjects with other malignant tumors. Has seriously mental disease. Uncontrolled clinically significant heart disease and Pulmonary dysfunction. Pregnancy or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma radiofrequency ablation arm<br>Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma | Procedure: Plasma radiofrequency ablation<br>* Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are completely removed through the bilateral nasal cavity. Then investigators use plasma radiofrequency ablation at low temperature to ablate the tumor tissue and normal tissue of the margin along the upper and lower surgical margin until no obvious tumor remained under the naked eye.<br>|
| Active Comparator: Electrocautery block resection arm<br>Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma | Procedure: Electrocautery block resection<br>* Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are continuously and completely removed through the bilateral nasal cavity. Then investigators separate the posterior part of the nasal cavity and the top wall of the nasopharynx along the bone of the nasopharyngeal fornix, cut the pharyngeal suture, and cut the two sides along the edge of the carina, and then merge along the anterior vertebral muscle surface to the midline incision. Along the the soft palate under the inferior margin, investigators horizontally cut the mucosa of the posterior wall of the nasopharynx, and completely frees the entire soft tissue of the posterior wall of the nasopharynx.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from randomisation to the date of disease progression or death from any causes. whichever came first. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from randomisation to the date of death from any causes. whichever came first. | 2 years | 
| Loco-regional relapse-free survival | Time from randomisation to the date of loco-regional recurrence. | 2 years | 
| Distant metastasis-free survival | Time from randomisation to the date of distant metastasis. | 2 years | 
| Incidence of surgery related complications | the proportion of patients with surgery related complications | 1 year | 
| Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) | Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before surgery, at the end of surgery, at 3 months after surgery, and at 6 months after surgery. | 1 year | 
| Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) | Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before surgery, at the end of surgery, at 3 months after surgery, and at 6 months after surgery. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent nasopharyngeal carcinoma, Plasma Radiofrequency Ablation, Electrocautery Block Resection