The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability
研究概览
简要总结
This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.
详细描述
The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-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
- •Age >/= 18 years
- •ECOG performance status 0-1
- •Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy.
- •Imaging as follows:
- •CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration
- •Whole body PET scan within 8 weeks of registration
- •Evaluation by a surgical oncologist to determine non-resectability
- •Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- •CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows:
- •ANC > 1,500 cell/mm3
- •Platelets > 100,000 cells/mm3
- •Hemoglobin > 8.0 g/dl (transfusion to obtain this value is permissible)
- •Additional labs within 14 days prior to registration
- •Creatinine <2mg/dl
- •Bilirubin <2mg/dl
- •AST and ALT < 2.5 x ULN
- •Patients must provide study specific informed consent prior to study entry.
排除标准
- •Metastatic disease as defined by the multi-disciplinary team
- •Prior anti-cancer therapy for a pancreatic tumor
- •Prior malignancy within the last 3 years.
- •Pregnant women or lactating women
- •Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
研究组 & 干预措施
Folririnox with SBRT
Folfirinox
- Oxaliplatin 85 mg/m² for over 2 hours,
- Leucovorin 400n mg/m² for over 2 hours,
- Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion
- Fluorouracil 400 mg/m² as a fast infusion over 15 minutes
- Fluorouracil 2400 mg/m² as a slow infusion over 46 hours
SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment.
干预措施: Folfirinox (Drug)
Folririnox with SBRT
Folfirinox
- Oxaliplatin 85 mg/m² for over 2 hours,
- Leucovorin 400n mg/m² for over 2 hours,
- Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion
- Fluorouracil 400 mg/m² as a fast infusion over 15 minutes
- Fluorouracil 2400 mg/m² as a slow infusion over 46 hours
SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability
时间窗: Assessed up to 24 months post treatment
Number of Participants With Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability. This is based on CTCAE to assess toxicity at specified time points by the treating physician.
次要结局
- Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months.(Assessed at 3 months, 6 months, 9 months and 12 months post-treatment)
研究者
Neal Edward Dunlap
Associate Professor
University of Louisville