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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04425265
• Other study ID #: SYSUCC-CMY-2020-2301
• Status: Recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: May 2025

Study information

• Verified date: June 2020
• Source: Sun Yat-sen University
• Contact: Ming-Yuan Chen, MD, PhD
• Phone: 86-20-8734-3361
• Email: chmingy[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: May 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

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

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrent Nasopharyngeal Carcinoma
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Time from randomisation to the date of disease progression or death from any causes.; whichever came first.	2 years
Secondary	Overall survival	Time from randomisation to the date of death from any causes. whichever came first.	2 years
Secondary	Loco-regional relapse-free survival	Time from randomisation to the date of loco-regional recurrence.	2 years
Secondary	Distant metastasis-free survival	Time from randomisation to the date of distant metastasis.	2 years
Secondary	Incidence of surgery related complications	the proportion of patients with surgery related complications	1 year
Secondary	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
Secondary	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