NCT01463501Unknown2 期
Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
详细描述
Patient Population:
Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0
Scheme:
Patients are randomized to 2 arms:
Arm A:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20cm from the incisors) or gastroesophageal junction are included.
- •No distant metastases (M0).
- •Patients will be stratified by stage (clinical N0 versus clinical N1).
- •Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
- •Resectable mediastinal nodes are eligible.
- •No prior chemotherapy for this malignancy.
- •No prior radiotherapy that would overlap the field(s) treated in this study.
- •Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
- •Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.
排除标准
- •Cancers of the cervical esophagus (< 20 cm are excluded).
- •Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
- •Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
- •Patients with biopsy proven metastatic celiac nodes are ineligible.
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 1 year
Assess the safety and tolerability based on NCI CTC V4.0
Scores of Quality of life
时间窗: 1 year
Assess the quality of life based on FACT-E.
次要结局
- Disease-free Survival(3 years)
- Overall Survival(3 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV Oropharynx, Hypopharynx, or Larynx CancerHuman Papilloma Virus InfectionStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the OropharynxStage III Verrucous Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Verrucous Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the LarynxStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Verrucous Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Verrucous Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Verrucous Carcinoma of the LarynxNCT02048020Jonsson Comprehensive Cancer Center26
Unknown
2 期
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung CancerNon-small Cell Lung CancerNCT01054482The First Affiliated Hospital of Guangzhou Medical University120
已完成
不适用
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment TrialEsophageal NeoplasmsNCT00907543Richard Malthaner96
已完成
2 期
Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver MetastasesRectal CancerLiver MetastasesNCT01643070Asan Medical Center38
终止
2 期
Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLCNon-Small Cell Lung CancerNCT00960297SCRI Development Innovations, LLC4