Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The role of adjuvant chemotherapy(ACT)
研究概览
简要总结
Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.
log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.
In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection
排除标准
- •patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information
结局指标
主要结局
The role of adjuvant chemotherapy(ACT)
时间窗: 1 year
The association between ACT and Overall Survival (OS) of patients
次要结局
- The role of adjuvant chemotherapy(ACT)(1 year)
研究者
Dong Bing Zhao
Deputy director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
