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| Name | Class |
|---|---|
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Sun Yat-Sen University Cancer Center | OTHER |
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
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The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage â… nasopharyngeal carcinoma.
At present, the newly diagnosed non metastatic nasopharyngeal carcinoma has achieved good therapeutic effect under the treatment scheme of intensity modulated radiotherapy. The 5-year survival rate of the newly diagnosed stage â… nasopharyngeal carcinoma was more than 95%. But at the same time, all patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury, which will affect the quality of life of patients to varying degrees. For stage â… nasopharyngeal carcinoma with the primary lesion confined to the nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without preventive treatment of cervical lymph nodes.
Our previous research results showed that endoscopic surgery could achieved similar survival outcomes but less adverse events than radiotherapy for Stage â… nasopharyngeal carcinoma with short diameter of retropharyngeal lymph nodes<0.4cm or short diameter of cervical lymph nodes<0.6 and negative PET/CT findings. However, if there is the same results for all stage I NPC patients is still unclear. Therefore, this study aims to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection combined with low-dose radiotherapy or bilateral upper neck lymph node dissection compared with conventional intensity-modulated radiotherapy.
When the patients participated in this study, the stage â… NPC patient of experimental group 1 received endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection and low-dose radiotherapy. Low dose radiotherapy target area: CTV1 (tumor bed area); For the primary lesion with negative margin but less than 3mm, the margin area should be included; For patients with extracapsular invasion of lymph nodes, the extracapsular invasion area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: low risk infiltration area. The prescription dose of intensity modulated radiotherapy: CTV1:36.00gy/15fr/2.40gy; CTV2:30.00gy/15fr/2.00gy. The patients in the stage â… in the experimental group 2 underwent endoscopic nasopharynx resection combined with retropharyngeal lymph node resection and bilateral upper neck lymph node dissection, without radiotherapy or chemotherapy after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery plus low dose radiotherapy | Experimental | Surgery: Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy. Radiotherapy: Low Dose Raiotherapy: Low dose radiotherapy target area: CTV1: tumor bed area; For cases where the margin of the primary lesion is negative but less than 3mm, the margin area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: Low risk infiltration area. Intensity modulated radiation therapy prescription dose: CTV1: 36.00Gy/15Fr/2.40Gy; CTV2: 30.00Gy/15Fr/2.00Gy. |
|
| Surgery | Experimental | Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy. Bilateral Upper Neck Lymph Node Dissection: the specific cleaning area is the lymph nodes upon the Hyoid bone regions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy | Procedure | in experimental arm 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Regional Relapse-Free Survival (LRRFS) | The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of serious complications | Common Adverse Event Evaluation Criteria (CTCAE) version 5.0 evaluates acute and late-stage subjective toxicity reactions. | 2 years |
| Overall Survival (OS) |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD,PhD | Contact | +8613903052650 | chmingy@email.sysu.edu.cn | |
| You-Ping Liu, PhD | Contact | +8613751763276 | liuyp78@email.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD,PhD | SUN yet-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 516000 | China |
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| Huazhong University of Science and Technology Union Shenzhen Hospital |
| OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First People's Hospital of Foshan | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
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| Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection | Procedure | in experimental arm 2 |
|
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
| 2 years |
| Distant Metastasis-Free Survival (DMFS) | The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit. | 2 years |
| Progression-Free Survival (PFS) | The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up. | 2 years |
| Score of QLQ-C30 | Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ-C30) before treatment, during treatment, after treatment and follow up. | 2 years |
| Score of H&N 35 | Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ-C30 and H&N 35) before treatment, during treatment, after treatment and follow up. | 2 years |
| Incidence of acute postoperative complications | The incidence of acute postoperative complications. | 2 weeks |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | 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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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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