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

Last updated: June 8, 2020
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Nasopharyngeal Cancer

Surgery

Treatment

N/A

Clinical Study ID

NCT04425265
SYSUCC-CMY-2020-2301
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 6 months disease free interval (defined as duration between the initialcourse of radiotherapy and recurrence)

  2. Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizingnasopharyngeal carcinoma.

  3. Resectable recurrent nasopharyngeal carcinoma: A) recurrent T1N0M0 according to the American Joint Committee on Cancer (AJCC) 8thstaging B) recurrent T2N0M0(the tumor was confined to the surface of theparapharyngeal 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

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

Total Participants: 248
Study Start date:
June 01, 2020
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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