PACER (Pancreatic AdenoCarcinoma With Electron Intraoperative Radiation Therapy): A Phase II Study of Electron Beam Intraoperative Radiation Therapy Following Chemoradiation in Patients With Pancreatic Cancer With Vascular Involvement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 199
- 试验地点
- 12
- 主要终点
- 2 Year Overall Survival
研究概览
简要总结
This research study is studying an intervention as a possible treatment for pancreatic cancer.
详细描述
In this research study, the investigators are researching how well IORT during surgery works in treating pancreatic cancer after 3-6 months of chemotherapy and external radiation therapy. IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy. The investigators believe that the administration of IORT after 3-6 months of chemotherapy will help to stop the cancer cells from growing.
The FDA (the U.S. Food and Drug Administration) has not approved IORT for this specific disease but it has been approved for other uses.
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
- •Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)
- •Previous completion of either stereotactic-body radiation therapy (SBRT) (minimum 24 Gy) or external beam irradiation (EBRT) (minimum 45 Gy)
- •Participation in any investigational drug study within 4 weeks preceding the start of study treatment is PERMITTED.
- •Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after IORT.
- •Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Evidence of disease progression or distant metastases.
- •Pregnant or lactating women
- •Treatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.
- •Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •An active infection requiring systemic therapy
- •Other serious medical conditions that the investigator feels might compromise study participation
研究组 & 干预措施
IORT
- IORT will be administered as determined to be best practice by the treating radiation oncologist,
- Electron beam intraoperative radiation therapy will occur in a hybrid operating room with a portable linear accelerator
干预措施: IORT (Radiation)
结局指标
主要结局
2 Year Overall Survival
时间窗: 2 years
Overall survival is defined as the time from IORT to death due to any cause, or is censored at the date of last follow-up, when applicable.
次要结局
- Median Progression Free Survival(2 years)
- Local Control(2 years)
- Adverse events associated with IORT(2 years)
研究者
Jennifer Wo
Principal Investigator
Massachusetts General Hospital