Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Efficacy - Progression Free Survival
研究概览
简要总结
To assess the ability of a combination of updated and approved modalities in the treatment of first line pancreatic cancer patients to increase the time to Progression Free Survival
详细描述
For resectable patient; surgery with Intraoperative Radiation Therapy (IORT). Radiation Therapy within 6-8 weeks after surgery followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery.
For marginally resectable patients; the patients will have 2-3 cycles of neoadjuvant chemotherapy of FOLFIRINOX and then restaged, undergo surgery with IORT within 2-4 weeks following chemotherapy. Then radiation therapy starting within 6-8 weeks. Followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles.
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 proven Exocrine Adenocarcinoma of the pancreas
- •Clinically resectable or marginally resectable disease
- •No prior radiation or chemotherapy for carcinoma of the pancreas
- •ECOG performance status of 0-1
- •Patients must be medically able to undergo surgical resection
- •Patients of child bearing potential must follow study specific precautions
- •Women that are lactating will not be excluded on the condition that they dispose their breast milk.
- •Adequate hematologic and biochemical parameters.
排除标准
- •Prior treatment for pancreatic cancer.
- •Concurrent investigational treatments.
- •Unresectable pancreatic mass.
- •Neuroendocrine Histological pancreatic cancer
- •Distant Metastatic disease
- •Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements
结局指标
主要结局
Efficacy - Progression Free Survival
时间窗: 2 years after last patient enrolled
Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.
次要结局
- Safety(2 years after last patient enrolled)