Has the Quota of Signet Ring Cells an Influence on Prognosis and Treatment Strategy in the Upper GI Tract Adenocarcinomas?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract
研究概览
简要总结
Background • A major increase in incidence of signet ring cell adenocarcinomas (ADCI) of the upper digestive tract in western countries
- Discordant results in the literature concerning the prognosis value of the presence of signet ring cells.
- Preliminary data suggesting (i) an advanced stage at time of diagnosis, (ii) more often in the form of carcinose, (iii) a more pejorative prognosis, (iv) a recurrence more frequent, more quickly, and more often in the form of peritoneal carcinose, (v) a chemo resistance (vi) the need for a specific therapeutic strategy compared to non-signet ring cell adenocarcinomas.
Primary objective To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract
Secondary objectives
- Impact of neoadjuvant CT on overall survival
- Impact and differential diagnostic value of linitis
- R0 resection rates
- 3 years recurrence free survival
- Overall 3 years survival
- Prognostic factors
- Prognostic value of the presence of a minority quota of signet ring cell
- Objective response rate after medical treatment (chemotherapy, radiochemotherapy) in non-resected patients
- Tolerance of (radio) chemotherapy for ADCI
Methodology Intention to treat retrospective case-control multicentric study A pairing on demographic criteria (age, sex, ASA score, center) and tumor criteria (TNM stage) will be done to ensure comparability in case control study groups.
Inclusion criteria All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.
For whom the first consultation took place between January 1997 and January 2010
Exclusion criteria Histological type other than adenocarcinoma Other localization than esogastric junction, esophagus or stomach
Planned study period The data will be collected over a period from January 1997 to January 2010.
The objective is to complete the data collection for summer 2010.
详细描述
stomach cancer signet ring cell carcinoma prognosis chemotherapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients taken care of, for a proven histologically adenocarcinoma (ADCI and ADNCI) of the esophagus, the esogastric junction, or the stomach, in surgical or medical oncology investigator centers, will be saved in a given database.
- •For whom the first consultation took place between January 1997 and January 2010
- •As they benefit from a medical and/or surgical support (primitive cancer being or not resected), whatever the metastatic or the recurrence situation was.
排除标准
- •Histological type other than adenocarcinoma
- •Other localization than esogastric junction, esophagus or stomach
结局指标
主要结局
To test the hypothesis that 5-year survival rate is significantly lower in the signet ring cells (SRC) adenocarcinoma when compared to non-SRC adenocarcinoma in the upper digestive tract
时间窗: participants are followed until death or time point at 31 september 2010
次要结局
- 3 year recurrence free survival(participants are followed until recurrence or time point at 31 september 2010)
- Overall 3 year survival according to tumor stage, node invasion, and tumor localization(participants are followed until death or time point at 31 september 2010)