A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Two-year Disease Free Survival.
研究概览
简要总结
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
详细描述
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
- •Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
- •Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of <
- •Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
- •Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
- •Patients must be aware of the investigational nature of the therapy and provide written informed consent.
- •Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
- •Patients must not have used any investigational agent in the month before enrollment into the study.
排除标准
- •Patients with neuroendocrine tumors are excluded.
- •Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
- •Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
研究组 & 干预措施
Oxaliplatin & gemcitabine with radiation
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
干预措施: gemcitabine (Drug)
Oxaliplatin & gemcitabine with radiation
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
干预措施: oxaliplatin (Drug)
Oxaliplatin & gemcitabine with radiation
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
干预措施: Radiation (Procedure)
结局指标
主要结局
Two-year Disease Free Survival.
时间窗: two years
The percent of patients alive and disease-free at two years.
次要结局
- Time to Treatment Failure(2 years)
- Overall Survival(5 years)