A Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin in Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Overall Survival at 18 Months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works in treating patients with pancreatic cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the overall 18-month survival of patients with radiographically resectable pancreatic adenocarcinoma treated with neoadjuvant gemcitabine and oxaliplatin followed by surgical resection and adjuvant gemcitabine.
Secondary
- To determine the safety, toxicity, and feasibility of this regimen in the neoadjuvant setting.
- To determine the feasibility of obtaining preoperative core tissue biopsies and the ability to use these biopsies to establish pathologic correlates of response following neoadjuvant therapy and to determine if xenografts can be developed from these core tissues.
- To determine the specific tumor marker response (CEA and CA19-9) to neoadjuvant therapy.
- To determine the prognostic accuracy of serum protein profiles in these patients.
- To determine the overall survival and patterns of tumor recurrence (local vs distant).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: proteomic profiling (Genetic)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: diagnostic laboratory biomarker analysis (Other)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: adjuvant therapy (Procedure)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: gemcitabine hydrochloride (Drug)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: oxaliplatin (Drug)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: protein expression analysis (Genetic)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: neoadjuvant therapy (Procedure)
Gemcitabine And Oxaliplatin
A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Overall Survival at 18 Months
时间窗: 18 months
Percentage of participants that were alive or survived at 18 months after randomization
次要结局
- Specific Tumor Marker Response (CEA) to Neoadjuvant Therapy(Baseline and 2 years)
- RECIST Radiologic Response to Neoadjuvant Therapy(2 years)
- Specific Tumor Marker Response (Ca 19-9) to Neoadjuvant Therapy(Baseline and 2 years)
- Overall Survival (Follow-Up Time)(From Baseline until 2 Years and Follow-Up, up to 120 months)