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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
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.
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
Time from randomisation to the date of disease progression or death from any causes. whichever came first.
Time frame: 2 years
Overall survival
Time from randomisation to the date of death from any causes. whichever came first.
Time frame: 2 years
Loco-regional relapse-free survival
Time from randomisation to the date of loco-regional recurrence.
Time frame: 2 years
Distant metastasis-free survival
Time from randomisation to the date of distant metastasis.
Time frame: 2 years
Incidence of surgery related complications
the proportion of patients with surgery related complications
Time frame: 1 year
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score 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.
Time frame: 1 year
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score 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.
Time frame: 1 year
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