Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
研究概览
简要总结
This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.)
- •Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
- •No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
- •Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both)
- •No prior chemotherapy or radiation therapy.
- •Ineligible for other high priority national or institutional studies.
- •Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females.
- •Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy.
- •Complete Blood Count and Complete Metabolic Profile:
- •Absolute Neutrophil Count > 1,500 μl White Blood Count > 3,000/μl Platelet count > 100,000/μl BUN < 1.5 x normal Creatinine < 1.5 normal Hemoglobin > 8.0 g/dl Serum Albumin > 3 mg/dl Total Bilirubin < 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase < 2.5 x ULN
- •Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
排除标准
- 未提供
研究组 & 干预措施
Group I
Patients with only venous involvement Treated with 6 cycles og GTX and then surgery
干预措施: Neoadjuvant gemcitabine, capecitabine, and docetaxel (Drug)
Group II
Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery
干预措施: Gemcitabine, capecitabine, docetaxel followed by radiotherapy (Drug)
结局指标
主要结局
To determine the effect of neoadjuvant regimen of GTX on the 2-year disease free survival rate
时间窗: 2 years
次要结局
- To describe the effect of neoadjuvant GTX regimen on resectability for those with arterial involvement and those with venous involvement, separately(12 weeks)
研究者
William Sherman
Associate Professor of Clinical Medicine
Columbia University