"An observational study to determine the incidence of Her2 positivity in 100 consecative gastric cancers"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of Her2 positivity in 100 consecutive Gastric cancer patients
研究概览
简要总结
Gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. We have very few options for patients with advanced disease.
The trastuzumab for Gastric Cancer (ToGA) trial, a pivotal randomized clinical trial of patients with HER-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-Her 2 therapy) in combination with chemotherapy. The median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; HR 0.74; p=0.0046) without unexpected toxicity including cardiac events. The survival benefit was most pronounced in the subgroup of high HER-2/neu protein overexpression (median overall survival of 16 months). Only 20% of the patients screened and subsequently enrolled for this study were found to be HER2-positive when utilizing both immunohistochemistry and FISH. Her2 testing is recommended for all patients with advanced gastric cancers and type III oesophageal adenocarcinomas.
Data on Indian patients is lacking. Hence, we plan to test for Her 2 in 100 patients with IHC and FISH in 2+ and 3+ patients.
| Study |
Population
N
Histology type
Location
|Intestinal (% +)
Diffuse (%+)
**Mixed/**Uk (%+)
GEJ
Stomach
|Tanner (1)
Finland
231
21.5
2
5
24
12
|Gravalos (2)
Spain
166
16
7
14
25
9.5
|Lordick (3)
International
1527
34
6
20
32
18
|Matsubara (4)
Japan
87
32.5
6
|Park (5)
Korea
161
8
1
|
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •100 consecutive patients with gastric cancer who have a pathology specimen at our site.
排除标准
- •If histopathology blocks were not available.
结局指标
主要结局
Rate of Her2 positivity in 100 consecutive Gastric cancer patients
时间窗: Total duration of 6 month
次要结局
- Not Applicable(Not Applicable)
