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

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Brief Title

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

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.

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.

Study Type

Interventional

Primary Outcome

Progression-free survival

Secondary Outcome

 Overall survival

Condition

Surgery

Intervention

Plasma radiofrequency ablation

Study Arms / Comparison Groups

 Plasma radiofrequency ablation arm
Description:  Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

248

Start Date

June 2020

Completion Date

May 2025

Primary Completion Date

June 2024

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 86-20-8734-3361, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04425265

Organization ID

SYSUCC-CMY-2020-2301

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

, ,

Verification Date

June 2020