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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma radiofrequency ablation arm | Experimental | Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma |
|
| Electrocautery block resection arm | Active Comparator | Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma radiofrequency ablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from randomisation to the date of disease progression or death from any causes. whichever came first. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from randomisation to the date of death from any causes. whichever came first. | 2 years |
| Loco-regional relapse-free survival | Time from randomisation to the date of loco-regional recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD, PhD | Contact | 86-20-8734-3361 | chmingy@mail.sysu.edu.cn | |
| You-Ping Liu, MD, PhD | Contact | 86-13751763276 | liuyp78@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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The sample size was updated according to external data from published study (PMID: 37974339).
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|
| Electrocautery block resection | Procedure | 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. |
|
| 2 years |
| Distant metastasis-free survival | Time from randomisation to the date of distant metastasis. | 2 years |
| Incidence of surgery related complications | the proportion of patients with surgery related complications | 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. | 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. | 1 year |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
|
| The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital) | Recruiting | Nanchang | Jiangxi | China |
|
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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