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

Sun Yat-sen University

Status: Enrolling

Conditions: Recurrent Nasopharyngeal Carcinoma; Surgery

Treatments: Procedure: Plasma radiofrequency ablation; Procedure: Electrocautery block resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04425265

SYSUCC-CMY-2020-2301

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Plasma radiofrequency ablation arm

Experimental group

Description:

Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma

Treatment:

Procedure: Plasma radiofrequency ablation

Electrocautery block resection arm

Active Comparator group

Description:

Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma

Treatment:

Procedure: Electrocautery block resection