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

NCT ID: NCT04425265

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2025-05-31

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.

Conditions

Surgery; Recurrent Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plasma radiofrequency ablation arm

Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma

Group Type: EXPERIMENTAL

Plasma radiofrequency ablation

Intervention Type: PROCEDURE

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 arm

Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma

Group Type: ACTIVE_COMPARATOR

Electrocautery block resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

Chief physician, Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming-Yuan Chen, MD, PhD

Role: CONTACT

chmingy@mail.sysu.edu.cn

86-20-8734-3361

Rui You, MD, PhD

Role: CONTACT

yourui@sysucc.org.cn

86-13580439820

Facility Contacts

Ming-Yuan Chen, Prof.

Role: primary

chmingy@mail.sysu.edu.cn

86-20-8734-3361

Other Identifiers

SYSUCC-CMY-2020-2301

Identifier Type: -

Identifier Source: org_study_id