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| Name | Class |
|---|---|
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Sun Yat-sen University | OTHER |
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
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The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .
Currently, the treatment of newly diagnosed non-metastatic nasopharyngeal carcinoma with intensity modulated radiotherapy as the core and chemotherapy with platinum-containing drugs has achieved good therapeutic outcomes. However, the toxicity and side effects caused by local radiotherapy greatly affect the quality of life of patients with nasopharyngeal carcinoma during treatment. In order to find a more "high-efficiency and low-toxicity" nasopharyngeal cancer treatment mode, combined with minimally invasive surgery for radical tumor treatment and radiotherapy and chemotherapy to eliminate potential micro-metastatic lesions,, Our team has previously carried out "prospective clinical trial of newly diagnosed operable nasopharyngeal carcinoma surgery combined with reduced target chemoradiotherapy versus conventional chemoradiotherapy", It has been prelim natively confirmed that gross tumor volume(GTV) and clinical tumor volume (CTV1) high-risk infiltrating area need not be recharacterized after the combined nasopharyngeal or non-combined retropharyngeal surgery and radical resection of cervical lesions. Only low risk infiltrating area (CTV2) was delineated and preventive irradiation of 54 Gy/33 times /45 days was administered, combined with induction or concurrent chemotherapy. Preliminary study results showed that it could further reduce the local recurrence of tumors and the overall curative effect while reducing the toxic side effects of treatment and achieve the therapeutic effect of increased efficacy and reduced toxicity.
Although compared to the conventional radiotherapy dose of 70Gy, postoperative reduced target radiotherapy has achieved a significant reduction in radiotherapy dose while ensuring tumor control, However, we are concerned that nearly 40% of patients still have ≥ grade 3 dry mouth, mucosal ulcer, mouth difficulty and dysphagia during or after treatment. Therefore, for newly diagnosed patients with surgically resectable nasopharyngeal carcinoma, we plan to conduct a prospective clinical trial comparing the survival prognosis and toxic side effects of newly diagnosed surgery combined with reduced dose radiotherapy compared with conventional reduced target radiotherapy combined with concurrent chemotherapy. To explore whether this treatment model can bring comparable survival benefits, lower toxic side effects and shorter treatment cycles for patients.
According to our team's previous research results and literature data, we designed the following scheme: patients with operable nasopharyngeal carcinoma were assigned to the control group and the experimental group. Control group: nasopharyngeal combined with or without combined retropharyngeal and neck lesions radical surgery, postoperative routine target reduction chemoradiotherapy at the same period. Experimental group: Patients underwent radical surgery with or without nasopharynx combined with retropharyngeal and cervical lesions, followed by concurrent low-dose radiotherapy and chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery plus target reduction Chemoradiotherapy | Active Comparator | Surgery: Endoscopic Nasopharyngectomy:Radical Reaction of the Primary Lesion Using Nasal Endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy. Neck lymph node dissection Selection of region where the possitive lymph nodes are located. Intensity modulated radiotherapy with GTV and CTV1 Reduction: CTV2:50.00Gy/25Fr/2.00Gy. Chemotherapy: cisplatin-based regimens. |
|
| surgery plus dose reduction Chemoradiotherapy | Experimental | Surgery: Endoscopic Nasopharyngectomy: Radical Reaction of the Primary Lesion Using Nasal Endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy. Neck lymph node dissection Selection of region where the possitive lymph nodes are located. Intensity modulated radiotherapy with CTV1 and CTV2 dose Reduction: CTV1:48.00-50.00Gy/20Fr/2.40-2.50Gy; CTV2:40.00Gy/20Fr/2.00Gy. Chemotherapy: cisplatin-based regimens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery combined with Target-reduction intensity-modulated radiotherapy | Radiation | in control arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional Recurrence-Free Survival Time (LRRFS) | The time interval between randomization and locoregional recurrence, or censored at the date of the last follow-up. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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. | 3 years |
| Incidence of Treatment-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD,PhD | Contact | 86-13903052650 | chmingy@email.sysu.edu.cn | |
| You-Ping Liu, PhD | Contact | 86-137517763276 | 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 Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 519000 | China |
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| Huazhong University of Science and Technology Union Shenzhen Hospital |
| OTHER |
| The First Affiliated Hospital of University of South China | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Nanchang City First Hospital | UNKNOWN |
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| Surgery combined with Dose-reduction intensity-modulated radiotherapy | Radiation | in experimental arm |
|
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The proportion of patients with treatment related adverse events according to NCI-CTCAE 5.0 and RTOG criteria.
| 1 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 censored at the date of the last follow-up. | 3 years |
| 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 treatment, during treatment, after treatment and follow up. | 3 years |
| 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 treatment, during treatment, after treatment and follow up. | 3 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. | 3 years |
| 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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