A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
In this study, the investigators designed a treatment regimen including the most active agents in pancreatic cancer which are gemcitabine and fluorouracil to be tested as a first line treatment. This regimen is expected to be less toxic than FOLFIRINOX and aiming at better outcomes.
详细描述
Metastatic cancer pancreas has been a challenge for oncologists over the years. It is a disease of limited survival and a very poor response to treatment. The median overall survival at five years is expected to be between 4-6% only. Adenocarcinoma is the most common type of pancreatic cancer. It is the tenth most common adult solid malignancy. Most of the new therapeutic modalities has proven to be non-beneficial in this disease including targeted and immunotherapy.
For many years, the first line of treatment for pancreatic cancer was gemcitabine either alone or in combinations. Recently, FOLFIRINOX has become the standard of care due to its overall survival benefit. However, it is a small benefit on the expense of great toxicity.
Patients with metastatic cancer pancreas are recruited to receive the test regimen. Baseline evaluation will be done either by CT scan or PET/CT. re-evaluation will be repeated after 3 months of treatment and at end of 6 months
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological evidence of adenocarcinoma of the pancreas
- •Radiological proof of metastatic disease as defined by AJCC
排除标准
- •patients with poor performance status (ECOG 4)
- •patients with organ dysfunction defined as: creatinine more than 1.6 mg/dl or bilirubin more than 3 mg/dl
- •patients with end stage renal disease who are under regular dialysis
- •other histologies of pancreatic cancer
- •irresectable pancreatic cancer if not metatatic
研究组 & 干预措施
Chemotherapy
Participants will receive the test protocol Gem-5FU on biweekly basis for 6 months with interim evaluation
Doses as follows:
Gemcitabine 1000 mg/m2, infusion over 30 min, D1, D15 Leucovorin 400 mg/m2 infusion over 30 min , D1, D15 5FU 400 mg/m2 I.V. shot D1, D15 5FU 2000 mg/m2 infusion over 46 hours D1 , D15
干预措施: Gemcitabine fluorouracil (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 6 months from enrollment
describes according to RECIST criteria
次要结局
- Adverse events (AE)(6 months from chemotherapy)
- Overall survival (OS)(One year from start of enrollment)
- Progression free survival (PFS)(One year from start of enrollment)
研究者
Ahmed Sohaib
Lecturer of Clinical oncology
Menoufia University