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临床试验/NCT01397019
NCT01397019已完成2 期

Chemotherapy for Patients With Locally Advanced Pancreatic Cancer With Additional Chemo-radiotherapy for Patients With Borderline Resectable Tumours

Per Pfeiffer3 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
56
试验地点
3
主要终点
2 year survival rate

研究概览

简要总结

Treating patients with initial local non-resectable pancreatic cancer with a combination of oxaliplatin, irinotecan & 5-FU(FOLFIRINOX), consolidated with chemoradiotherapy in potentially resectable patients, will result in a high rate of tumor shrinkage allowing subsequent resection in patients with initial borderline resectable tumors and improved overall survival for all patients.

详细描述

Pancreatic cancer (PC) is the third most common gastrointestinal malignancy and one of the top ten leading causes of cancer deaths in the Western world. Patients with PC can be divided into three subgroups; resectable (rPC), locally advanced (LAPC) and metastatic (mPC). For patients with rPC surgery offers the best chance for long term survival. However it is estimated that only 20% of patients have rPC at the time of diagnosis. For patients with LACP, invasion of local large vessels is most often the cause for non-resectability. The median survival of these patients is between 6 to 12 months and long term survival in is extremely rare. The optimal treatment of LAPC is controversial. Treatment strategies vary between attempts to "downstage" the tumour to rPC, or treat the patients in a palliative setting only. Phase II studies and retrospective series have evaluated various treatments regimens and strategies including chemotherapy and radiotherapy (RT) alone or in combination - chemoradiotherapy (CRT). Results from these trials give no clear answer regarding the best treatment strategy. However, data from several studies shows that treatment of LAPC may result in shrinkage of the tumour, and thus potentially lead to a resection; also data suggests that CRT after chemotherapy improves treatment efficacy. Recent data from patients with mPC has show a combination of oxaliplatin, irinotecan and 5-FU (FOLFIRINOX) increases response rates from 10% to 30% and median survival to 11.1 months. The promising efficacy makes it natural to attempt this treatment in patients with LAPC.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-metastatic pancreatic cancer
  • Performance status 0-1
  • Bilirubin < 1.5 UNL
  • Written informed consent

排除标准

  • no prior abdominal radiotherapy
  • no prior chemotherapy for pancratic cancer
  • no severe comorbidity
  • patients must be able to undergo potential abdominal surgery

研究组 & 干预措施

FOLFIRINOX

Experimental

干预措施: Oxaliplatin, irinotecan, 5-FU & leucovorin (Drug)

结局指标

主要结局

2 year survival rate

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
Per Pfeiffer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Per Pfeiffer

Professor

Odense University Hospital

研究点 (3)

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