A Phase II Study Evaluating the Rate of R0 Resection (Microscopically Negative Margins) After Induction Therapy With 5- Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan (FOLFIRINOX) in Patients With Borderline Resectable or Locally Advanced Inoperable Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
研究概览
简要总结
The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
- •Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
- •No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
- •Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age
- •Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
- •Patients must have adequate blood counts at baseline and blood chemistry levels
- •Patient has ECOG Performance Status 0 to 1
排除标准
- •Patients with islet cell neoplasms excluded
- •Patients with known brain metastases
- •Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •Known infection with HIV, hepatitis B or hepatitis C
- •Major surgery or vascular device placement within 4 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 other clinical protocol or investigational trial
- •Metastatic disease on radiological staging
- •Prior malignancy within last 3 years
- •Significant cardiac disease
- •Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk
- •peripheral sensory neuropathy > or equal to grade 2 at baseline
研究组 & 干预措施
FOLFIRINOX
Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of chemo. If found amendable to surgery, patient will proceed with resection, and type of resection (R0 or R1) will be recorded.
干预措施: Irinotecan, Oxaliplatin, Leucovorin, 5-FU (Drug)
结局指标
主要结局
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.
时间窗: 2 years
次要结局
- Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)(2 years)
- Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.(2 years)
- Overall Survival(2 years)
- Number of Participants Who Experienced Toxicity(2 years)