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

Primary Purpose

Surgery, Recurrent Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Plasma radiofrequency ablation

Electrocautery block resection

About this trial

This is an interventional treatment trial for Surgery focused on measuring recurrent nasopharyngeal carcinoma, Plasma Radiofrequency Ablation, Electrocautery Block Resection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 6 months disease free interval (defined as duration between the initial course of radiotherapy and recurrence)
Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma.
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
Age: 18-70 years old.
Subjects must sign an informed consent form.

Exclusion Criteria:

Karnofsky score (KPS)≤70.
Has known Subjects with other malignant tumors.
Has seriously mental disease.
Uncontrolled clinically significant heart disease and Pulmonary dysfunction.
Pregnancy or breast feeding.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plasma radiofrequency ablation arm

Electrocautery block resection arm

Arm Description

Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma

Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma

Outcomes

Primary Outcome Measures

Progression-free survival

Time from randomisation to the date of disease progression or death from any causes. whichever came first.

Secondary Outcome Measures

Overall survival

Time from randomisation to the date of death from any causes. whichever came first.

Loco-regional relapse-free survival

Time from randomisation to the date of loco-regional recurrence.

Distant metastasis-free survival

Time from randomisation to the date of distant metastasis.

Incidence of surgery related complications

the proportion of patients with surgery related complications

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

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.

Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

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.

Full Information

NCT ID

NCT04425265

First Posted

June 4, 2020

Last Updated

June 8, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04425265

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Recruiting

Study Start Date

June 2020 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgery, Recurrent Nasopharyngeal Carcinoma

Keywords

recurrent nasopharyngeal carcinoma, Plasma Radiofrequency Ablation, Electrocautery Block Resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Plasma radiofrequency ablation arm

Arm Type

Experimental

Arm Description

Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma

Arm Title

Electrocautery block resection arm

Arm Type

Active Comparator

Arm Description

Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma

Intervention Type

Procedure

Intervention Name(s)

Plasma radiofrequency ablation

Intervention Description

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

Intervention Name(s)

Electrocautery block resection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Time from randomisation to the date of disease progression or death from any causes. whichever came first.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

Time from randomisation to the date of death from any causes. whichever came first.

Time Frame

2 years

Title

Loco-regional relapse-free survival

Description

Time from randomisation to the date of loco-regional recurrence.

Time Frame

2 years

Title

Distant metastasis-free survival

Description

Time from randomisation to the date of distant metastasis.

Time Frame

2 years

Title

Incidence of surgery related complications

Description

the proportion of patients with surgery related complications

Time Frame

1 year

Title

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

Description

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.

Time Frame

1 year

Title

Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 6 months disease free interval (defined as duration between the initial course of radiotherapy and recurrence) Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma. 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 Age: 18-70 years old. Subjects must sign an informed consent form. Exclusion Criteria: Karnofsky score (KPS)≤70. Has known Subjects with other malignant tumors. Has seriously mental disease. Uncontrolled clinically significant heart disease and Pulmonary dysfunction. Pregnancy or breast feeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming-Yuan Chen, MD, PhD

Phone

86-20-8734-3361

chmingy@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Rui You, MD, PhD

Phone

86-13580439820

yourui@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming-Yuan Chen, Prof.

Phone

86-20-8734-3361

chmingy@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Ming-Yuan Chen, Prof.

12. IPD Sharing Statement

Plan to Share IPD

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

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