A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease-specific survival
研究概览
简要总结
This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRINOX-base chemotherapy, and SBRT, increases the 3-year survival rate. A total of 101 patients will be enrolled, and these patients will receive IORT of 10 to 20 Gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).
详细描述
Treatment outcomes of borderline resectable pancreatic cancer are still poor even after completion of FOLFIRINOX-based chemotherapy and radical resection. A growing body of literature is demonstrating that Stereotactic body radiation therapy (SBRT) and Intraoperative radiotherapy (IORT), within a multimodal approach, allow to obtain better oncological outcome, at the price of low to negligible rates of morbidity and mortality. The investigators hypothesize that a "total neoadjuvant" scenario, with the best current therapy, based on up to 6 months of FOLFIRINOX (minimum 4), SBRT and IORT (in situ or after surgery) would increase the disease-specific survival of borderline resectable pancreatic cancer patients. An historical cohort will be used as a comparison group.
Considering the intention-to-treat design and the institutional rates of chemotherapy completion and exploration/resection of borderline resection pancreatic cancer patients, a total of 100 patients will be enrolled in this phase II trial. Patients submitted to IORT, will receive IORT of 10 to 20 Gy according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Biopsy-proven, previously untreated borderline resectable PC, defined according to the NCCN guidelines v1.2019;
- •Age 18-80 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Adequate bone marrow function (absolute neutrophil count ≥1500 per cubic millimeter; platelet count ≥100.000 per cubic millimeter; hemoglobin level ≥10 g per deciliter), liver function (serum total bilirubin level ≤1.5 times the upper limit of the normal range), and renal function (creatinine clearance ≥50 ml per minute);
- •Ability to understand the characteristics of the clinical trial;
- •Written informed consent.
排除标准
- •• Ampullary, biliary, or duodenal adenocarcinoma; pancreatic adenocarcinoma in the background of an intraductal papillary mucinous neoplasia (IPMN), other uncommon pancreatic adenocarcinomas (acinar-cell, squamous, giant-cell osteoclastic-like);
- •Invasive cancer in the last 5 years requiring radiation therapy to the upper abdomen or chemotherapy;
- •Symptomatic heart failure or coronary artery disease;
- •Pregnant or lactating women;
- •Impaired mental state or language problems.
研究组 & 干预措施
IORT group
Intraoperative administration of 10 to 20 Gy after surgery or as an "in situ" treatment in case resection will not be performed
干预措施: Intraoperative radiotherapy (Radiation)
结局指标
主要结局
Disease-specific survival
时间窗: 36 months
次要结局
- Progression-free survival(36 months)
- Rate of margin-free surgery(30 days)
- Rate of surgical complications(Up to 90 days after surgery)
- Resection rate(Intraoperative)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(36 months)
研究者
Salvatore Paiella, MD
Principal Investigator
Universita di Verona