Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plasma radiofrequency ablation, Electrocautery block resection.
- Who it may be relevant to
- Registry conditions: Surgery, Recurrent Nasopharyngeal Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma.
Overview
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
- Procedure Plasma 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. - Procedure Electrocautery 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 so
Primary outcome measures
- Progression-free survival [Time frame: 2 years]
Secondary outcome measures (6)
- Overall survival [Time frame: 2 years]
- Loco-regional relapse-free survival [Time frame: 2 years]
- Distant metastasis-free survival [Time frame: 2 years]
- Incidence of surgery related complications [Time frame: 1 year]
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [Time frame: 1 year]
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- Subjects must sign an informed consent form.
Exclusion criteria
- Karnofsky score (KPS)≤70.
- Has known Subjects with other malignant tumors.
- Has seriously mental disease.
- Uncontrolled clinically significant heart disease and Pulmonary dysfunction.
- Pregnancy or breast feeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
- The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital) — Nanchang
Identifiers
NCT: NCT04425265 · SYSUCC-CMY-2020-2301