A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,216
- 试验地点
- 1
- 主要终点
- 3-years overall survival (OS)
研究概览
简要总结
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
详细描述
Test grouping:
Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;
Specific chemotherapy regimens:
Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life
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
- •Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
- •Esophageal squamous cell carcinoma proved by histopathology;
- •Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
- •According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
- •ECOG 0-1; life expectancy > 6 months;
- •No chemotherapy was used before selection;
- •No history of radiotherapy;
- •No surgical treatment;
- •No serious allergic history;
- •Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;
排除标准
- •History of malignant tumors in other parts;
- •Duplicate carcinoma of the esophagus;
- •Pregnant or lactating patients;
- •Fertility but not using contraceptive measures;
- •Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
- •During the active period of infectious diseases;
- •Participate in other clinical trials at present or within four weeks before enrollment;
- •Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
- •After esophageal stent placement;
- •Cases with perforation tendency;
- •Have a history of organ transplantation.
- •Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
- •Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
结局指标
主要结局
3-years overall survival (OS)
时间窗: up to 3 years
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
5-years overall survival (OS)
时间窗: up to 5 years
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
次要结局
- Objective response rate (ORR) Objective response rate (ORR)(through study completion, an average of 36 month)
- 3-year progression-free survival (PFS)(up to 3 years)
- 5-year progression-free survival (PFS)(up to 5 years)