A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Type and the severity of side effects
研究概览
简要总结
This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.
详细描述
Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.
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
- •Medically fit for major pancreatic surgery
- •No evidence of metastases
- •No prior resection
- •Arterial involvement limited to a single major vessel and is resectable
- •Tumour-free margins could be achieved
- •Acceptable length of vessel
- •Mass considered otherwise resectable by current standards
- •Less than 70 years old
- •Performance status <=2
- •Has pancreatic adenocarcinoma
- •Adequate bone marrow and organ function
- •Therapeutic heparin is allowed
- •Taking chronic erythropoietin are permitted
- •Not pregnant
- •Agree to use contraception
- •Able to provide written consent
排除标准
- •Aortic involvement
- •Involvement of 2 major arterial trunks
- •SMV/portal venous occlusion, cannot be reconstructed
- •Extensive venous involvement, no arterial involvement
- •Disease progression on neo-adjuvant treatme
- •Concurrent cancer diagnosis
- •Other malignancies unless all therapy completed, no disease for >=3 years
- •Prior radiotherapy or chemo within 1 year, to pancreas
- •Bone marrow transplant/stem cell rescue
- •Major surgery <4 wks prior
- •Distant metastases
- •Renal dysfunction
- •Pulmonary insufficiency
- •History of cardiac disease
- •Active systemic infection(s) or any other related illnesses
- •Known HIV, HBV, HCV
- •History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy
- •Conditions interfering with patient participation
- •Known or suspected allergy to study drugs
- •Pregnant or breast-feeding
- •Therapeutic coumadin
- •More than or equal to Grade 2 pre-exiting peripheral neuropathy
研究组 & 干预措施
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles.
Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles.
Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction)
Surgery: Tumor resection and arterial resection/reconstruction
干预措施: Nab-paclitaxel (Drug)
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles.
Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles.
Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction)
Surgery: Tumor resection and arterial resection/reconstruction
干预措施: Gemcitabine (Drug)
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles.
Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles.
Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction)
Surgery: Tumor resection and arterial resection/reconstruction
干预措施: Radiation Therapy (Radiation)
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles.
Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles.
Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction)
Surgery: Tumor resection and arterial resection/reconstruction
干预措施: Surgical Resection (Procedure)
结局指标
主要结局
Type and the severity of side effects
时间窗: 5 years
次要结局
- Average length of hospital stay per patient(5 years)
- Number of surviving patients at 30-days after surgery(30 days after surgery)
- Time to Progression(5 years)
- Number of surviving patients at 1 year after treatment(1 year)
- Number of patients who disease has not progressed(2 years)
- Number of patients that are able to receive surgery after chemoradiation(5 years)
- Number of surviving patients at 90-days after surgery(90 days after surgery)
- Number of patients who need to be re-admitted to the hospital at 90-days after surgery(90 days after surgery)