Study of Neoadjuvent Chemotherapy Followed by SBRT in Patients With Resectable and Borderline Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT
研究概览
简要总结
The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.
详细描述
Primary Objectives:
- To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT
Secondary Objectives:
- To assess the following disease control endpoints: pathological response, disease-free survival, overall survival, failure pattern (local vs. distant) and time to development of distant metastases
- To assess safety of the SBRT regimen
Exploratory objectives
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
- •Age ≥ 18 years
- •Pathologic confirmation of pancreatic ductal adenocarcinoma
- •Resectable disease (determined by treating surgeon)
- •Patients planning to receive neoadjuvant Folfirinox as part of their standard of care treatment
- •No evidence of distant organ metastatic disease
- •Eastern Cooperative Oncology Group Performance status 0-1
- •Ability to understand and the willingness to sign informed consent document
- •Adequate organ function, defined by the following laboratory values, at the time of study entry:
- •Hemoglobin ≥ 10 g/dL (transfusions acceptable)
- •Absolute Neutrophil Count ≥ 0.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Creatinine ≤ 1.5x institutional upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min
- •Total bilirubin ≤ 2x institutional ULN
- •Aspartate aminotransferase test (AST)/ Alanine Aminotransferase Test (ALT) ≤ 3x institutional ULD
排除标准
- •Severe/uncontrolled intercurrent illness that, in the opinion of the patient's treating physicians, would prevent the patient from receiving either multi agent chemotherapy, high-dose radiation, or undergoing resection of the pancreatic tumor
- •Prior therapy for PDAC
- •Prior radiation to the upper abdomen (RT to other sites acceptable)
- •Inability to undergo port or PICC line placement
- •Active gastric or duodenal ulcer
- •Tumor invasion of the intestinal or gastric lumen
- •Active hepatitis B or other active serious infections
- •Pregnant and breastfeeding women are excluded. Women of child-bearing potential must have a negative urine or serum pregnancy test and be willing to use acceptable methods of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study treatment
- •Life expectancy of < 3 months
- •Patients with contraindications to either PET scan or MRI (e.g., pacemaker/ICD) will NOT be excluded from study participation. Such patients will be treated per protocol but will not be required to undergo PET-MRI.
研究组 & 干预措施
Preoperative Chemotherapy + SBRT
Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines.
After 6 cycles of neoadjuvant therapy are completed, patients will undergo imaging with pancreatic protocol CT and PET-MRI to assess disease status . Patients without evidence of disease progression at the end of 6 cycles of neoadjuvant treatment will proceed to SBRT followed by surgical resection.
Following surgery, patients will receive an additional 6 cycles of FOLFIRINOX chemotherapy.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Preoperative Chemotherapy + SBRT
Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines.
After 6 cycles of neoadjuvant therapy are completed, patients will undergo imaging with pancreatic protocol CT and PET-MRI to assess disease status . Patients without evidence of disease progression at the end of 6 cycles of neoadjuvant treatment will proceed to SBRT followed by surgical resection.
Following surgery, patients will receive an additional 6 cycles of FOLFIRINOX chemotherapy.
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT
时间窗: 1 year after surgery date
次要结局
- Rate of margin negative resection(Surgery Date (4 weeks [+/- 14 days] from end of SBRT))
- Local control rate(from date of surgery until date of first documented local failure, up to 5 years)
- Rate of grade 3-4 non hematological toxicity rates(Date of first fraction of SBRT through 30 days (+/-14) after surgery date)
- Time to development of distant metastases(From surgery date to date of first documented metastatic disease, up to 5 years)
- Pathological tumor response grade(Surgery Date (4 weeks [+/- 14 days] from end of SBRT))
- Rate of progression free survival(From surgery date to first documented date of progression, up to 5 years)
- Overall survival(From surgery date to date of death, up to 5 years)
- Site of first failure(From surgery date to date of first documented metastatic disease, up to 5 years)
研究者
Susannah Ellsworth
Assistant Professor of Radiation Oncology
Indiana University