Randomized Phase II-III Trial of Peri- or Post-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Event-free survival at 1 year (phase II)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, epirubicin hydrochloride, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II/III trial is studying how well gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine, works when given before and/or after surgery in treating patients with stage I or stage II pancreatic cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To assess the proportion of patients who are event-free (defined as disease progression, local recurrence, distant metastasis, new tumor, or death) at 1 year after neoadjuvant therapy comprising gemcitabine hydrochloride with cisplatin, epirubicin hydrochloride, and capecitabine (PEXG), and adjuvant chemotherapy comprising gemcitabine hydrochloride or PEXG regimen in patients with resectable stage I or II adenocarcinoma of the pancreas. (phase II)
- To assess whether the best experimental regimen, which will be selected on the basis of the phase II part of the trial, is able to improve overall survival when compared to standard adjuvant gemcitabine in these patients. (phase III)
Secondary
- To assess radiological, biochemical, and pathological response rate (neoadjuvant arm only) in these patients.
- To assess surgical resection rate, surgical mortality and morbidity, and proportion of patients with negative surgical margins.
- To assess lymph node status in these patients.
- To determine tolerability of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
adjuvant PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months
干预措施: capecitabine (Drug)
adjuvant PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months
干预措施: cisplatin (Drug)
adjuvant PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months
干预措施: epirubicin (Drug)
adjuvant PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 6 months
干预措施: gemcitabine (Drug)
perioperative PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery
干预措施: capecitabine (Drug)
perioperative PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery
干预措施: cisplatin (Drug)
perioperative PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery
干预措施: epirubicin (Drug)
perioperative PEXG
cisplatin and epirubicin at 30 mg/mq, gemcitabine at 800 mg/mq and capecitabine at 1250 mg/mq/day per os for 14 days every 14 days for 3 months before surgery and 3 months after surgery
干预措施: gemcitabine (Drug)
Adjuvant Gemcitabine
Adjuvant Gemcitabine at 1000 mg/mq for 3 weeks every 4 weeks for 6 months
干预措施: gemcitabine (Drug)
结局指标
主要结局
Event-free survival at 1 year (phase II)
时间窗: every 3 months
CT scan
次要结局
- Radiological, biochemical, and pathological response rate (neoadjuvant arm only)(after 3 months of induction therapy)
- Tolerability(every 2 weeks during therapy)
- Surgical mortality and morbidity(immediately after surgery)
- Proportion of patients with negative surgical margins(immediately after surgery)
- Lymph node status(immediately after surgery)
- Surgical resection rate(immediately after surgery)