A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres) MRI and PET/CT Sub-studies
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 1,103
- 试验地点
- 41
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cisplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, and small molecule tyrosine kinase inhibitors, such as lapatinib, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Lapatinib targets a specific growth receptor, HER-2. Chemotherapy together with bevacizumab or lapatinib, in HER-2 positive tumours, may kill more tumor cells.
PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving combination chemotherapy together with bevacizumab works compared with combination chemotherapy alone in treating patients with previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study is studying the safety of adding lapatinib to chemotherapy in patients with HER-2 positive previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study will also assess the feasibility of timely HER-2 testing and estimate the HER-2 positivity rate in this patient population.
详细描述
OBJECTIVES:
Primary
- Assess the safety and efficacy of neoadjuvant and adjuvant chemotherapy comprising epirubicin hydrochloride, cisplatin, and capecitabine with or without bevacizumab in patients with previously untreated, resectable gastric, gastroesophageal junction or lower oesophageal cancer.
- Assess the safety of neoadjuvant and adjuvant chemotherapy comprising epirubicin hydrochloride, cisplatin, and capecitabine with or without lapatinib in patients with HER-2 positive previously untreated, resectable gastric, gastroesophageal junction or lower oesophageal cancer.
OUTLINE: This is a multicenter, randomized, open-label, controlled study. Patients are randomized to 1 of 4 treatment arms.
- Arm I and II: Patients receive epirubicin hydrochloride IV and cisplatin IV over 4 hours on day 1 and capecitabine orally twice daily on days 1-21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
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 —(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
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: bevacizumab (Biological)
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: capecitabine (Drug)
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: cisplatin (Drug)
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: Epirubicin (Drug)
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: adjuvant therapy (Procedure)
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: conventional surgery (Procedure)
ECX + Bevacizumab
ECX + Bevacizumab
干预措施: neoadjuvant therapy (Procedure)
Epirubicin, Cisplatin and Capecitabine
ECX chemotherapy
干预措施: capecitabine (Drug)
Epirubicin, Cisplatin and Capecitabine
ECX chemotherapy
干预措施: cisplatin (Drug)
Epirubicin, Cisplatin and Capecitabine
ECX chemotherapy
干预措施: Epirubicin (Drug)
Epirubicin, Cisplatin and Capecitabine
ECX chemotherapy
干预措施: adjuvant therapy (Procedure)
Epirubicin, Cisplatin and Capecitabine
ECX chemotherapy
干预措施: conventional surgery (Procedure)
Epirubicin, Cisplatin and Capecitabine
ECX chemotherapy
干预措施: neoadjuvant therapy (Procedure)
ECX + Lapatinib
ECX + Lapatinib
干预措施: capecitabine (Drug)
ECX + Lapatinib
ECX + Lapatinib
干预措施: cisplatin (Drug)
ECX + Lapatinib
ECX + Lapatinib
干预措施: Epirubicin (Drug)
ECX + Lapatinib
ECX + Lapatinib
干预措施: adjuvant therapy (Procedure)
ECX + Lapatinib
ECX + Lapatinib
干预措施: conventional surgery (Procedure)
ECX + Lapatinib
ECX + Lapatinib
干预措施: neoadjuvant therapy (Procedure)
ECX + Lapatinib
ECX + Lapatinib
干预措施: Lapatinib (Drug)
结局指标
主要结局
Safety
时间窗: at the end of phase II and phase III
Efficacy
时间窗: end of trial
Overall survival
时间窗: end of trial
次要结局
- Treatment-related morbidity(end of trial)
- Feasibility(end of trial)
- Surgical resection rates(end of trial)
- Cost-effectiveness(end of trial)
- Quality of life(end of trial)
- Response rates to pre-operative treatment(at phase II review and at end of trial)
- Disease-free survival(end of trial)
- HER-2 Positivity Rate(End of trial)
- Feasibility of centralised HER-2 testing(After 60 patients tested and then after 110 patients tested and then at end of trial)
研究者
Professor David Cunningham
ST03 Chief Investigator, Professor David Cunningham
Medical Research Council
