Actively Recruiting
A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2026-05-08
500
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating plasma radiofrequency ablation at low temperature compared to electrocautery block resection at high frequency for patients with localized recurrent nasopharyngeal carcinoma. This randomized controlled trial aims to determine whether the low-temperature plasma radiofrequency technique leads to better survival outcomes. The study is sponsored by Sun Yat-sen University and focuses on a surgical approach to treat this specific type of cancer recurrence. Participants will be randomly assigned to one of two treatment groups. One group will receive plasma radiofrequency ablation under nasal endoscope guidance, where the tumor and surrounding tissue are carefully removed and ablated at low temperature until no visible tumor remains. The other group will undergo electrocautery block resection, involving a detailed surgical removal of the tumor and surrounding tissues through the nasal cavity. Both procedures are performed via the nasal passage under endoscopic view. Throughout the study, participants will be monitored for progression-free survival over two years, which is the primary outcome measure. Additional assessments include overall survival, relapse-free survival, distant metastasis-free survival, and complications related to surgery within one year. Quality of life will be evaluated using standardized questionnaires at one year. The total duration of follow-up will extend to two years to assess these outcomes and monitor participant well-being after surgery.
CONDITIONS
Brief Title
Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 6 months disease-free interval after initial radiotherapy
- Diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma
- Resectable recurrent nasopharyngeal carcinoma (rT1-3N0-3M0) confined to nasopharyngeal mucosa or nearby areas, more than 0.5 cm from internal carotid artery
- Cervical lymph node lesions not infiltrating cervical spine, brachial plexus, cervical muscles, or internal carotid artery
- Age between 18 and 70 years
- Signed informed consent form
You will not qualify if you...
- Karnofsky score less than or equal to 70
- Presence of other malignant tumors
- Serious mental disease
- Uncontrolled significant heart disease or pulmonary dysfunction
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive either plasma radiofrequency ablation at low temperature or electrocautery block resection at high frequency to remove localized recurrent nasopharyngeal carcinoma.
1 treatment visit (in-person)
Duration - Up to 2 years
Participants are monitored for surgery-related complications and survival outcomes including progression-free survival and quality of life for up to 2 years after treatment.
Periodic follow-up visits over 2 years
Trial Site Locations
Total: 3 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
3
The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital)
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
Y
You-Ping Liu, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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