Low-temperature plasma radiofrequency ablation versus high-frequency electrocautery resection 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.
This trial will see if low-temperature plasma radiofrequency ablation works better than high-frequency electrocautery resection for adults with localized recurrent nasopharyngeal carcinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 3 sites (Guangzhou, Guangdong and 2 other locations) |
| Trial ID | NCT04425265 on ClinicalTrials.gov |
What this trial studies
This is a randomized, multicenter trial comparing two surgical approaches for resectable localized recurrent nasopharyngeal carcinoma: low-temperature plasma radiofrequency ablation and high-frequency electrocautery block resection. Adults with rT1-3N0-3M0 recurrent disease occurring at least six months after prior radiotherapy and meeting performance and safety criteria will be randomized to one of the two procedures. Outcomes will include survival measures and perioperative surgical outcomes such as complications and recovery. The goal is to determine whether the low-temperature plasma technique yields better survival or surgical tolerability than standard electrocautery.
Who should consider this trial
Good fit: Adults aged 18–70 with histologically confirmed, resectable localized recurrent nasopharyngeal carcinoma (rT1-3N0-3M0), at least six months since prior radiotherapy, KPS >70, and who can provide informed consent are ideal candidates.
Not a fit: Patients with unresectable or metastatic disease, serious uncontrolled cardiac or pulmonary disease, other active malignancies, significant psychiatric illness, KPS ≤70, or who are pregnant or breastfeeding are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the low-temperature plasma approach could offer a more convenient surgical option with better survival or fewer complications for patients with localized recurrent nasopharyngeal carcinoma.
How similar studies have performed: Smaller case series and nonrandomized reports suggest plasma radiofrequency ablation may reduce thermal injury and speed recovery, but direct randomized comparisons with electrocautery for recurrent nasopharyngeal carcinoma are limited.
Eligibility criteria
Show full inclusion / exclusion 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: 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. 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.
Where this trial is running
Guangzhou, Guangdong and 2 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
- The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital) — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Study coordinator: Ming-Yuan Chen, MD, PhD
- Email: chmingy@mail.sysu.edu.cn
- Phone: 86-20-8734-3361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.