Multicenter Randomized Controlled Trial of Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Local Regional Relapse-Free Survival (LRRFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance Status Score 0-1 points.
- •Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- •Patients with primary nasopharyngeal lesions evaluated as surgically resectable before chemotherapy, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus or pterygoid process). Clinical stage: T1-3N1-3M0, T2-3N0M0 (Stage II-IVA) according to AJCC v
- •Patients with cervical lymph nodes evaluated as surgically resectable before chemotherapy, including cervical lymph nodes with no invasion (encasement) of the common or ICA, the epidermis, mediastinal structures, prevertebral fascia, or cervical vertebrae.
- •Patients with retropharyngeal lymph nodes evaluated as surgically resectable before chemotherapy, including simple RPLNs with intact capsule or RPLNs ≤ 1.5cm with mouth opening range > 4cm.
- •Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- •Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
排除标准
- •Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
- •Suffering severe cardiopathy or pulmonary dysfunction with cardiac or pulmonary function no more than grade
- •Extensive recurrent primary tumour beyond the resectable area such as extensive invasion of the skull base or a distance from the tumour margins to the internal carotid artery of less than 0·5 cm.
- •Retropharyngeal lymph node involved or adjacent to primary nasopharyngeal lesions (less than 0·5 cm).
- •Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
- •During pregnancy or lactation.
- •Other patients that the chief physician considered as illegal for this trial.
研究组 & 干预措施
Surgery Plus Target-reduction Chemoradiotherapy
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
干预措施: Gemcitabine (Drug)
Surgery Plus Target-reduction Chemoradiotherapy
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
干预措施: Cisplatin (Drug)
Surgery Plus Target-reduction Chemoradiotherapy
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
干预措施: surgery (Procedure)
Surgery Plus Target-reduction Chemoradiotherapy
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
干预措施: Target-reduction intensity-modulated radiotherapy (Radiation)
Regular Chemoradiotherapy
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
干预措施: Gemcitabine (Drug)
Regular Chemoradiotherapy
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
干预措施: Cisplatin (Drug)
Regular Chemoradiotherapy
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
干预措施: regular intensity-modulated radiotherapy (Radiation)
结局指标
主要结局
Local Regional Relapse-Free Survival (LRRFS)
时间窗: 3 years
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.
次要结局
- Overall Survival (OS)(3 years)
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(3 years)
- Progress-free survival (PFS)(3 years)
- Incidence of treatment related acute complications(1 years)
- Regional Relapse-Free Survival (RRFS)(3 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(3 years)
- Incidence of treatment related late complications(3 years)
研究者
Ming-Yuan Chen
Professor, Chief Physician
Sun Yat-sen University