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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Recurrent Nasopharyngeal Carcinoma
• Intervention / Treatment: Procedure: Plasma radiofrequency ablation; Procedure: Electrocautery block resection

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming-Yuan Chen, MD, PhD; Phone Number: 86-20-8734-3361; Email: chmingy@mail.sysu.edu.cn
• Study Contact Backup: Name: You-Ping Liu, MD, PhD; Phone Number: 86-13751763276; Email: liuyp78@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Ming-Yuan Chen, Prof.; Phone Number: 86-20-8734-3361; Email: chmingy@mail.sysu.edu.cn
      • Principal Investigator: Ming-Yuan Chen, Prof.
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Ming-Yuan Chen, Ph.D; Phone Number: 13903052650; Email: chmingy@mail.sysu.edu.cn
      • Contact: You-Ping Liu, Ph.D; Phone Number: 13751763276; Email: liuyp78@mail.sysu.edu.cn
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital)
      • Contact: Ming-Yuan Chen, Ph.D; Phone Number: 86-13903052650; Email: chmingy@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 6 months disease free interval (defined as duration between the initial course of radiotherapy and recurrence)
2. Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma.
3. Resectable recurrent nasopharyngeal carcinoma: rT1-3N0-3M0 A) The tumor is confined to the nasopharyngeal mucosa, or the surface of the parapharyngeal space, or the bottom wall of the sphenoid sinus, and is more than 0.5cm away from the internal carotid artery B) The cervical lymph node lesions do not infiltrate the cervical spine, brachial plexus, cervical muscles, and internal carotid artery.
4. Age: 18-70 years old.
5. Subjects must sign an informed consent form.

Exclusion Criteria:

1. Karnofsky score (KPS)≤70.
2. Has known Subjects with other malignant tumors.
3. Has seriously mental disease.
4. Uncontrolled clinically significant heart disease and Pulmonary dysfunction.
5. Pregnancy or breast feeding.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plasma radiofrequency ablation arm; Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma	Procedure: Plasma radiofrequency ablation; 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.
Active Comparator: Electrocautery block resection arm; Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma	Procedure: Electrocautery block resection; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: recurrent nasopharyngeal carcinoma; Plasma Radiofrequency Ablation; Electrocautery Block Resection
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
• Other Study ID Numbers: SYSUCC-CMY-2020-2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No