NCT04009265招募中3 期
Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 819
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.
详细描述
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants volunteer to participate the study and signed the informed consent.
- •Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
- •No antineoplastic treatments before operation.
- •According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
- •WHO PS score: 0-1;
- •Age and gender: 18-75 years old, male and female unlimited;
- •Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.
排除标准
- •The surgical approach is left thoracic approach;
- •Patients with severe postoperative complications who cannot receive adjuvant therapy;
- •Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer.
- •Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
- •Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency;
- •Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
- •Known or suspected allergy to chemotherapeutic drugs.
结局指标
主要结局
Overall Survival
时间窗: 5-year overall survival
overall survival rate of each arms
次要结局
- Adverse Events(1 year)
- Scores of Quality of Life(5 years)
- Disease Free Survival(5-year disease free survival)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic StrokeIschemic Stroke, AcuteBrain DiseasesCerebrovascular DisordersNCT04973332Sinomed Neurovita Technology Inc.218
尚未招募
4 期
CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AMLRelapsed/Refractory AMLNCT06763666Nanfang Hospital, Southern Medical University172
尚未招募
不适用
Medial Enhancement Technique for the Treatment of Old Femoral Neck FracturesFracture of Neck of FemurNCT06713031Chinese PLA General Hospital400
已完成
2 期
Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 InfectionSARS-CoV-2 (COVID-19) InfectionAdvanced or Metastatic Hematological or Solid TumorNCT04333914Centre Leon Berard19
已完成
不适用
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue ReconstructionFull-thickness Skin DefectsDegloving InjuriesCrush InjuriesLaceration of SkinSurgical WoundInfectionGun Shot WoundCellulitisSkin CancerNecrotizing FasciitisNCT04091672Avita Medical65