Low-temperature plasma radiofrequency ablation versus high-frequency electrocautery resection for localized recurrent nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.