NCT01771146Unknown不适用
A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer
研究概览
简要总结
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)
详细描述
Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.
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
- •18 years of age or older
- •Male or non-pregnant and non-lactating female
- •Histologically or cytologically confirmed adenocarcinoma of pancreas
- •Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range).
- •Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7):
- •0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
- •1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
- •Signed study consent form
排除标准
- •<18 years of age
- •Pregnant or lactating female
- •Patient has islet cell neoplasms
- •Patient has known brain metastases
- •Patient has metastatic disease
- •Active secondary malignancies
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •Known infection with hepatitis B, hepatitis C, or cirrhosis
- •Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
- •Prior chemotherapy or radiation for pancreatic cancer
- •History of allergy or hypersensitivity to the study drugs
- •Patient is enrolled in any outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
- •Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled congestive heart failure (CHF), or prior myocardial infarction (MI) last 6-months
- •Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
- •Peripheral sensory neuropathy ≥ to grade 2 at baseline
- •Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
- •Study consent form not signed
研究组 & 干预措施
Neoadjuvant FOLFIRINOX Regimen
Other
Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection
干预措施: FOLFIRINOX Regimen (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer
时间窗: Up to 5 years
次要结局
- • R0 resection as defined as microscopically negative margins(Up to 5 years)
- • The length of time from diagnosis (enrollment) to death(Up to 5 years)
- • Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis(Up to 5 years)
研究者
研究点 (1)
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