Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 试验地点
- 72
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To assess whether administrating chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared with continuation of the same CT in patients with unresectable, locally advanced adenocarcinoma of the pancreas.
Secondary
- To assess whether erlotinib hydrochloride combined with gemcitabine hydrochloride and administered as maintenance treatment increases progression-free survival compared with gemcitabine hydrochloride alone and without maintenance treatment.
- To evaluate the response rate in the CT and chemoradiotherapy (CRT) arms.
- To evaluate tolerance to erlotinib hydrochloride as maintenance treatment after the end of CT or CRT.
- To study the predictive molecular factors (i.e., survivin, K-ras, EGFR, PTEN, or AKT) of survival.
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 120 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
Arm 1 (A1) - Gemcitabine
Gemcitabine 2 months, then stop until progression
干预措施: gemcitabine hydrochloride (Drug)
Arm 1 (A1) - Gemcitabine
Gemcitabine 2 months, then stop until progression
干预措施: laboratory biomarker analysis (Other)
Arm 2 (B1) Gemcitabine + Erlotinib
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
干预措施: erlotinib hydrochloride (Drug)
Arm 2 (B1) Gemcitabine + Erlotinib
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
干预措施: gemcitabine hydrochloride (Drug)
Arm 2 (B1) Gemcitabine + Erlotinib
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
干预措施: laboratory biomarker analysis (Other)
Arm 3 (A2) CRT
A2 CRT then stop until progression
干预措施: capecitabine (Drug)
Arm 3 (A2) CRT
A2 CRT then stop until progression
干预措施: laboratory biomarker analysis (Other)
Arm 3 (A2) CRT
A2 CRT then stop until progression
干预措施: radiation therapy (Radiation)
Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
干预措施: capecitabine (Drug)
Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
干预措施: erlotinib hydrochloride (Drug)
Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
干预措施: laboratory biomarker analysis (Other)
Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study
an interim analysis is planned when 196 deaths will be observed
次要结局
- Relationship between biological markers and survival(From baseline to death, assessed up to 8 years after the beginning of the study)
- Progression-free survival(time from the date of the first randomization to the date of progressive disease or death, assessed up to 8 years after the beginning of the study.)
- tolerance to erlotinib(from start of treatment until the event has resolved or stabilized or until death)