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Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Plus Target-reduction Chemoradiotherapy | Experimental | Surgery: Endoscopic nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy or da Vinci robotics. Neck lymph node dissection: Selective neck dissection of the region where the positive lymph nodes are located. Induction Chemotherapy for stage III-IVa: Gemcitabine, 1000 mg/m2, Day 1 and Day 8, Q3W, 3 cycles Cisplatin, 80 mg/m2, Day 1, Q3W, 3 cycles Intensity-modulated Radiotherapy with GTV and CTV1 reduction: CTV2 : 54.12Gy/33Fr/1.64Gy Concurrent Chemotherapy: Cisplatin, 100 mg/m2, intravenously, Day 1, Q3W during radiotherapy |
|
| Regular Chemoradiotherapy | Active Comparator | Induction Chemotherapy for stage III-IVa: Gemcitabine, 1000 mg/m2, intravenously within 30min, Day 1 and Day 8, Q3W, 3 cycles Cisplatin, 80 mg/m2, intravenously, Day 1, Q3W, 3 cycles Intensity-modulated Radiotherapy: GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy GTVrnd (retropharyngeal lymph nodes): 69.96Gy/33Fr/2.12Gy GTVnd: 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy Concurrent Chemotherapy: Cisplatin, 100 mg/m2, intravenously, Day 1, Q3W during radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | for induction chemotherapy |
|
| 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. | 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 |
| Progress-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-yuan Chen, MD, PhD | Contact | 02087342422 | chmingy@mail.sysu.edu.cn | |
| Rui You, MD, PhD | Contact | 13580439820 | chmingy@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-yuan Chen, MD, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Cisplatin | Drug | for induction and concurrent chemotherapy |
|
| regular intensity-modulated radiotherapy | Radiation | in active comparator arm |
|
| surgery | Procedure | in experimental arm |
|
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| Target-reduction intensity-modulated radiotherapy | Radiation | in experimental arm |
|
Progress-free survival is calculated from the date of randomization to the date of the first progression of any site or death or censored at the date of the last follow-up.
| 3 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. | 3 years |
| Regional Relapse-Free Survival (RRFS) | The RRFS was defined as the duration from the date of random assignment to the date of regional relapse 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. | 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. | 3 years |
| Incidence of treatment related acute complications | The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria. | 1 years |
| Incidence of treatment related late complications | The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria. | 3 years |
| Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 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 |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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