NCT02384811Unknown2 期
Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Local control rate
研究概览
简要总结
The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Joined the study voluntarily and signed informed consent form;
- •Age 18-75；ECOG 0-2
- •Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
- •T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
- •No radiotherapy, chemotherapy or other treatments pre(post)surgery
- •PS ECOG 0-2
- •Life expectancy of more than 3 months
- •Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN • Renal function: creatinine < 1.5 x ULN
- •No immuno-deficiency
- •Use of an effective contraceptive for adults to prevent pregnancy.
排除标准
- •Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- •Participation in other interventional clinical trials within 30 days
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- •Drug addiction, Alcoholism or AIDS
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- •Unsuitable to be enrolled in the trial in the opinion of the investigators
研究组 & 干预措施
Radiation group
Experimental
Radiation therapy
干预措施: radiation (Radiation)
结局指标
主要结局
Local control rate
时间窗: 2 years
次要结局
- Overall survival(5 year)
- Safety: Frequencies of treatment-related adverse event categories by NCI-CTC(3 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing ColonoscopyAnalgesiaNCT04470128Haisco Pharmaceutical Group Co., Ltd.180
已完成
2 期
Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical CancerCervical AdenocarcinomaStage IB Cervical CancerStage II Cervical CancerStage III Cervical CancerNCT02880007Institut de Cancérologie de Lorraine48
招募中
1 期
A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic MalignanciesMultiple Myeloma (MM)Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedDouble Hit LymphomaHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedChronic Lymphocytic Leukemia (CLL)Triple Hit LymphomaNCT05908409IDP Discovery Pharma S.L.37
进行中（未招募）
2 期
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.Non Small Cell Lung CancerNCT05020457Sichuan Baili Pharmaceutical Co., Ltd.69
招募中
1 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor TypesSolid TumorNCT04300556Eisai Inc.182