Efficacy and Safety of Neo-Radiochemotherapy Followed Surgery Compared With Definitive Radiochemotherapy in Patients With Initial Unresectable Esophageal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.
详细描述
- Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who down stage from inoperable to operable after neoadjuvant treatment;
- Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
- Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.
Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day
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
- Double (Investigator, Outcomes Assessor)
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
- •Thoracic esophageal cancer patients or esophagogastric junction cancer patients, with locally advanced unresectable tumor, clinically identified before treatment as T4bNxM0 or lymph node metastases (LNM)invading adjacent structures according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 8th ed.
- •Initial unresectable assessed by surgeon.
- •Patients able to tolerate surgery.
- •Untreated patients who have not received any antitumor therapy.
- •Life expectancy > 6 months.
- •Age: 18-70 years.
- •White blood cell count ≥4.0×10^9/L, ANC(absolute neutrophil count) ≥1.5×10^9/L, thrombocyte count ≥100×10^9/L, hemoglobin ≥90 g/L; normal liver and kidney functions.
- •WHO PS(Performance Status): 0-
- •Patients who understood the study and gave signed informed consent.
排除标准
- •Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery.
- •Patients with hemorrhage or complicated hemorrhage.
- •Other uncontrollable patients who are not suitable for surgery.
- •Patients who deny to accept surgery.
- •Pregnant or lactating women.
- •Patients who agree without acknowledgement as a result of psychological, family or social factors.
- •Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade ≥2 peripheral neuropathy.
- •Patients who have ever had malignant tumors other than esophageal cancer.
- •Patients with a history of diabetes for >10 years with unsatisfactory control of blood glucose level.
- •Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery.
- •Patients with severe infection.
- •Patients with uncontrolled diabetes, random blood glucose > 200mg/L, fasting glucose >140mg/L.
- •Patients with other severe disease, such as myocardial infarction in the last 6 months.
- •Patients who participate in other clinical trials right now or in the last 4 weeks.
研究组 & 干预措施
Definitive Radiochemotherapy
Concurrent Radiochemotherapy:
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
干预措施: Definitive Radiochemotherapy (Radiation)
Definitive Radiochemotherapy
Concurrent Radiochemotherapy:
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
干预措施: Neoadjuvant Radiochemotherapy followed by surgery (Procedure)
Neoadjuvant Radiochemotherapy followed by surgery
Concurrent Radiochemotherapy:
Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
干预措施: Definitive Radiochemotherapy (Radiation)
Neoadjuvant Radiochemotherapy followed by surgery
Concurrent Radiochemotherapy:
Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
干预措施: Neoadjuvant Radiochemotherapy followed by surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: 5 years
Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy
Disease-free survival
时间窗: 3 years
Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy.
次要结局
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment(5 years)