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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04425265
Enrollment
500
Registered
2020-06-11
Start date
2020-06-30
Completion date
2028-12-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Nasopharyngeal Carcinoma, Surgery

Keywords

recurrent nasopharyngeal carcinoma, Plasma Radiofrequency Ablation, Electrocautery Block Resection

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.

Interventions

PROCEDUREPlasma radiofrequency ablation

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.

PROCEDUREElectrocautery block resection

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.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The sample size was updated according to external data from published study (PMID: 37974339).

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survival2 yearsTime from randomisation to the date of disease progression or death from any causes. whichever came first.

Secondary

MeasureTime frameDescription
Overall survival2 yearsTime from randomisation to the date of death from any causes. whichever came first.
Loco-regional relapse-free survival2 yearsTime from randomisation to the date of loco-regional recurrence.
Distant metastasis-free survival2 yearsTime from randomisation to the date of distant metastasis.
Incidence of surgery related complications1 yearthe proportion of patients with surgery related complications
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)1 yearScore 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)1 yearScore 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.

Countries

China

Contacts

CONTACTMing-Yuan Chen, MD, PhD
chmingy@mail.sysu.edu.cn86-20-8734-3361
CONTACTYou-Ping Liu, MD, PhD
liuyp78@mail.sysu.edu.cn86-13751763276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026