Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma
A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma.
1 other identifier
interventional
500
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Jun 2020
Longer than P75 for not_applicable surgery
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 8, 2026
May 1, 2026
6.4 years
June 4, 2020
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Time from randomisation to the date of disease progression or death from any causes. whichever came first.
2 years
Secondary Outcomes (6)
Overall survival
2 years
Loco-regional relapse-free survival
2 years
Distant metastasis-free survival
2 years
Incidence of surgery related complications
1 year
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
1 year
- +1 more secondary outcomes
Study Arms (2)
Plasma radiofrequency ablation arm
EXPERIMENTALPlasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma
Electrocautery block resection arm
ACTIVE COMPARATORElectrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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: rT1-3N0-3M0 A) The tumor is confined to the nasopharyngeal mucosa, or the surface of the parapharyngeal space, or the bottom wall of the sphenoid sinus, and is more than 0.5cm away from the internal carotid artery B) The cervical lymph node lesions do not infiltrate the cervical spine, brachial plexus, cervical muscles, and internal carotid artery.
- Age: 18-70 years old.
- Subjects must sign an informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000, China
The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital)
Nanchang, Jiangxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician, Proffessor
Study Record Dates
First Submitted
June 4, 2020
First Posted
June 11, 2020
Study Start
June 30, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share