Low-dose Radiotherapy as a Chemo-potentiator of a Induction Chemotherapy Regimen With Gem-based Doublets and Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).
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
- •Pathologically confirmed adenocarcinoma of the pancreas
- •Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging but were found unresectable at surgery
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment
- •Patients with radiographically assessable disease
- •Adequate bone marrow, hepatic and renal function: -Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L. -Aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 x upper limit of normal (ULN). -Total bilirubin < 2 mg/dL. Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should decrease to < 2 mg/dL prior to study entry. - Creatinine < 3 mg/dL or Creatinine clearance > 40 mL/min (calculated according to Cockroft and Gault)
排除标准
- •Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
- •Gastric or duodenal obstruction
- •Previous peripheral neuropathy
- •Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
- •Malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder
研究组 & 干预措施
Gem-based doublets with LDR & sequential SBRT
Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
干预措施: LDR (Radiation)
Gem-based doublets with LDR & sequential SBRT
Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
干预措施: Gem-based doublets (Drug)
Gem-based doublets with LDR & sequential SBRT
Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
干预措施: SBRT (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: 1 year
defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1
次要结局
- Overall survival(1 year)
- Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))(every 3 months, up to 1 year)
研究者
Bruno Meduri
Medical Doctor
Azienda Ospedaliero-Universitaria di Modena