跳至主要内容
临床试验/CTRI/2013/03/003461
CTRI/2013/03/003461招募中不适用

"An observational study to determine the incidence of Her2 positivity in 100 consecative gastric cancers"

Tata Memorial centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月20日最近更新:
适应症

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)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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