NCT00522795已完成2 期
BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete Pathologic Response
研究概览
简要总结
Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
详细描述
32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
- •Patients may have celiac adenopathy
- •There must be no evidence of distant organ metastases
- •No prior chemotherapy or radiation for esophageal cancer
- •Patients must be > 18 years of age, and non pregnant
- •Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2.0 and bilirubin < 1.5 x ULN-ECOG performance status 0-
- •Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible
- •No contraindications to esophagectomy
- •Signed informed consent
排除标准
- •Active or uncontrolled infection
- •Patients must not have other coexistent medical condition that would preclude protocol therapy.
- •Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
研究组 & 干预措施
PPX with cisplatin and radiation
Experimental
PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation
干预措施: PPX with cisplatin and radiation (Drug)
结局指标
主要结局
Complete Pathologic Response
时间窗: At Surgery approximately 4weeks after last treatment
Per pathology review post surgery
次要结局
未报告次要终点
研究者
howard safran
Principle Investigator
Brown University
研究点 (1)
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