Neoadjuvant FOLFIRINOX and Chemoradiation Followed by Definitive Surgery and Postoperative Gemcitabine for Patients with Borderline Resectable Pancreatic Adenocarcinoma: an Intergroup Single-Arm Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 14
- 主要终点
- Completion rate of all preoperative and operative therapy
研究概览
简要总结
This pilot clinical trial studies combination chemotherapy and radiation therapy before surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer. Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
详细描述
The purpose of this study is to evaluate a new treatment program for patients with borderline resectable pancreas cancer in order to determine what effects, good and bad, chemotherapy and chemoradiation have on your cancer and to see if it allows safe surgery.
Primary Objectives:
- To assess the accrual rate of this study.
- To assess the rate of treatment-related toxicity and treatment delay during preoperative therapy.
- To assess the rate of completion of all preoperative and operative therapy.
Secondary Objectives:
- To assess the macroscopic (R0/R1) resection rate.
- To estimate the rate of radiographic and histopathologic response to preoperative therapy.
- To estimate the time to locoregional and distant recurrence.
- To assess overall survival (OS).
- To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies and to assess the quality of these nucleic acids using a sequencing-based assessment of tumor DNA.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: oxaliplatin (Drug)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: irinotecan (Drug)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: leucovorin (Drug)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: 5-fluorouracil (Drug)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: capecitabine (Drug)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: radiation (Radiation)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: surgery (Procedure)
mFOLFIRINOX, chemoradiation, surgery and gemcitabine
Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m^2 IV over 46-48 hours).
Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same.
Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.
干预措施: gemcitabine (Drug)
结局指标
主要结局
Completion rate of all preoperative and operative therapy
时间窗: Up to 30 weeks
Accrual rate, calculated by total number of patients accrued divided by number of months from the date the study is opened at the fifth site to the evaluation date
时间窗: Up to 3 years
Rate of treatment-related toxicity during preoperative therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4
时间窗: Up to 30 days after completion of study treatment
Rate of treatment delay (greater than 4 weeks) during preoperative therapy
时间窗: Up to 28 weeks
次要结局
- Macroscopic (R0/R1) resection rate defined as number of patients achieved R0 or R1 resection during surgery divided by number of evaluable patients(At the time of surgery)
- Histopathologic response rate defined as number of patients who achieved CR or PR determined according to histopathologic examination during pre-operative therapy divided by the number of evaluable patients(Up to 18 weeks)
- Time to locoregional recurrence(From the date of registration to the date of the first documented locoregional recurrence, assessed up to 3 years)
- Time to distant recurrence(From the date of registration to the date of the first documented distant recurrence, assessed up to 3 years)
- Radiographic response rate defined as number of patients who achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during pre-operative therapy divided by the number of evaluable patients(Up to 18 weeks)
- Overall survival(From the date of registration to the date of the death due to all causes, assessed up to 3 years)