Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Recurrence-free Survival as Measured by CT Scan
研究概览
简要总结
The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.
The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.
详细描述
The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years) at the time of signing informed consent form
- •Understand and voluntarily sign informed consent form
- •Able to adhere to study visit schedule and other protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •Absolute neutrophil count ≥ 1500 / mm³
- •Platelet count ≥ 100,000 / mm³
- •Resectable pancreatic adenocarcinoma
- •Pathologic diagnosis of pancreatic adenocarcinoma
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
- •A history of renal dysfunction (serum creatinine > 1.8 mg/dL)
- •Presence of active infection
- •Untreated second malignancy
- •Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)
研究组 & 干预措施
Gemcitabine / Cisplatin
Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
干预措施: Gemcitabine (Drug)
Gemcitabine / Cisplatin
Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Recurrence-free Survival as Measured by CT Scan
时间窗: Every 3 months and then every 6 months for 2 more years after resection
Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.
次要结局
- Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression(At the time of resection)