NCT02782182终止1 期
Perioperative FOLFIRINOX for Patients With Resectable Pancreatic Adenocarcinoma: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection
研究概览
简要总结
The purpose of this study is to see whether it is possible to give 8 doses of a combination of chemotherapy called FOLFIRINOX before surgery in subjects whose pancreas cancer can be removed with surgery.
详细描述
Primary Objective: To evaluate the percentage of pancreatic cancer patients able to complete the full 4 months of preoperative chemotherapy and undergo a resection.
Secondary Objectives
- To assess the percentage of patients able to complete all therapy, including preoperative chemotherapy, surgery, and postoperative therapy.
- To assess treatment-related toxicity during preoperative therapy
- To assess intra-operative and post-operative complications
- To assess the histopathologic (R0/R1) resection rate after preoperative therapy
- To determine disease free survival (DFS) for patients who undergo resection.
- To determine progression free survival (PFS) for all patients
- To determine overall survival (OS) from the date of first 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
- 未提供
排除标准
- •Patients who have had previous chemotherapy or radiotherapy for pancreatic adenocarcinoma prior to entering the study.
- •Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
- •Patients who are receiving any investigational agents.
- •Patients with borderline resectable, locally advanced or metastatic disease.
- •History of allergic reactions attributed to 5-FU, leucovorin, irinotecan or oxaliplatin or to compounds of similar chemical or biologic composition.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active liver disease including viral or non-viral hepatitis and cirrhosis, chronic diarrhea or inflammatory disease of the colon or rectum, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study. mFOLFIRINOX is a regimen containing more than one chemotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with mFOLFIRINOX, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
- •HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with mFOLFIRINOX. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- •Currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years.
- •Pre-existing neuropathy greater than grade
- •Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn's disease, ulcerative colitis).
研究组 & 干预措施
FOLFIRINOX+surgery
Experimental
4 cycles of pre-operative FOLFIRINOX, followed by surgery, followed by 2 more cycles of FOLFIRINOX
干预措施: FOLFIRINOX (oxaliplatin, leucovorin, irinotecan) (Drug)
结局指标
主要结局
Percentage of patients able to complete 4 months of preoperative chemotherapy and undergo a resection
时间窗: 4 months
Measured by percentage of successes/failures
次要结局
- R0/R1 resection rates(6 months)
- Disease free survival(Up to 5 years)
- Progression free survival(Up to 5 years)
- The extent of preoperative chemotherapy, surgery, and adjuvant chemotherapy.(6 months)
- Presence of adverse events(6 months)
- Intraoperative and post-op complications(Within 6 weeks post surgery)
- Overall survival(Up to 5 years)
研究者
研究点 (1)
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