NCT00931203已完成2 期
A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
National Health Research Institutes, Taiwan1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
研究概览
简要总结
This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free survival and overall survival.
详细描述
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
The secondary objectives of this study are to determine:
- Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.
- Negative resection margins (circumferential resection margin) rate.
- Downstaging rate.
- Sphincter preservation rate
- Locoregional and distant failure rate.
- Overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with resectable or potentially resectable adenocarcinoma of the rectum.
- •Clinical stage by Magnetic Resonance Image (MRI) of pelvis, ultrasonography of liver and Chest X ray: AJCC T2 N1-2M0 or T3-4 N0-2M0 (patients who require diverting loop colostomy are eligible). Nuclear medicine study (whole body bone scan or PET scan) can be performed if clinically indicated.
- •Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
- •Age greater than 18 years and < 80 years, ECOG performance status < 2
- •Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
- •WBC > 3.5 x109/L, neutrophil count > 1.5x109/L, platelet count > 100x109/L, serum bilirubin < 1.25xULN (upper limit of normal), AST/ALT < 3x ULN, serum creatinine < 1.25xULN.
- •Informed consent signed.
排除标准
- •Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
- •History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
- •Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
- •Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
- •History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
- •Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry.
- •Patients taking warfarin or other anticoagulating medicine.
结局指标
主要结局
The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer.
时间窗: 10 weeks
次要结局
- 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer.(> 28 weeks)
- Negative resection margins (circumferential resection margin) rate.(> 28 weeks)
- Downstaging rate.(> 28 weeks)
- Sphincter preservation rate.(> 28 weeks)
研究者
研究点 (1)
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