TCTR20170704001招募中3 期
Randomized study of high-dose (60-64 Gy) versus standard-dose (50 Gy) Intensity-Modulated Radiation Therapy (IMRT) for the trimodality therapy of patients with squamous cell carcinoma of thoracic esophagus.
Ratchadaphiseksomphot Endowment Fund0 个研究点目标入组 172 人开始时间: 2017年7月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Confirmed histopathologic diagnosis of primary (non-recurrent) squamous cell carcinoma of thoracic esophagus
- •2.T2-T4b, N0-3, M0 (Appendix 2)
- •3.Age 18-75 years
- •4.Karnofsky performance scale 60-100
- •5.Acceptable laboratory investigation: WBC ≥ 3,000/μl, platelets ≥ 100,000/μl; serum creatinine ≤ 1.6 mg/dl or creatinine clearance ≥ 60 ml/min using the following formula:
- •Estimated Creatinine Clearance = [140 †age (y)] x Body weight (kg) x 0.85 if female/ [72 x Serum creatinine (mg/dl)]
- •6.Weight loss < 20%
- •7.Dysphagia in any grade
- •8.Signed study-specific informed consent form prior to study entry
排除标准
- •1.Prior chest radiotherapy; prior systemic chemotherapy; prior major esophageal surgery.
- •2.Patients with multiple primary carcinomas of the esophagus.
- •3.Patients with TE fistula or metastatic disease (other than supraclavicular or celiac nodes).
- •4.Pregnant or lactating women or men unable or unwilling to practice contraception.
- •5.Patients with an uncontrolled diabetes (the blood sugar level was more than 180 mg/dL at the time of the PET scan), heart disease, hypertension, other uncontrolled serious medical or mental illnesses.
- •6.Patients who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.
研究者
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