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

Not Applicable

Recruiting

• Conditions: Surgery; Recurrent Nasopharyngeal Carcinoma
• Interventions: Procedure: Plasma radiofrequency ablation; Procedure: Electrocautery block resection

• Registration Number: NCT04425265
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-08
• Last Update Submitted: 2020-06-08
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2024-06
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma radiofrequency ablation arm	Plasma radiofrequency ablation	Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma
Electrocautery block resection arm	Electrocautery block resection	Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years	Time from randomisation to the date of disease progression or death from any causes.; whichever came first.

Secondary Outcome Measures

Name	Time	Method
Incidence of surgery related complications	1 year	the proportion of patients with surgery related complications
Overall survival	2 years	Time from randomisation to the date of death from any causes. whichever came first.
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)	1 year	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.
Loco-regional relapse-free survival	2 years	Time from randomisation to the date of loco-regional recurrence.
Distant metastasis-free survival	2 years	Time from randomisation to the date of distant metastasis.
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)	1 year	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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China