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.
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.
Karnofsky score (KPS)≤70.
Has known Subjects with other malignant tumors.
Has seriously mental disease.
Uncontrolled clinically significant heart disease and Pulmonary dysfunction.
Parallel
Plasma radiofrequency ablation
Procedure/SurgeryUnder 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.
Electrocautery block resection
Procedure/SurgeryUnder 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.
Progression-free survival
Time from randomisation to the date of disease progression or death from any causes. whichever came first.
Overall survival
Time from randomisation to the date of death from any causes. whichever came first.
Loco-regional relapse-free survival
Time from randomisation to the date of loco-regional recurrence.
Distant metastasis-free survival
Time from randomisation to the date of distant metastasis.
Incidence of surgery related complications
the proportion of patients with surgery related complications
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