Peritoneal Recurrence Among pT4 Colon Cancer Tumors: Epidemiology, Oncologic Outcomes and Risk-stratification Model. Results From an Observational Retrospective Multicenter Long-term Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,152
- 试验地点
- 1
- 主要终点
- Metachronous peritoneal carcinomatosis
研究概览
简要总结
This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors.
Based on a sample size calculation of 1152 patients, a retrospective review of a three year period of every participant hospitals, 50 in total, of different characteristics, was stablished.
Demographic, clinical, operative, histologic and oncologic follow-up variables were recorded.
详细描述
This is an observational retrospective cohort study to determine metachronous peritoneal carcinomatosis in a specific subgroup of colon cancer patients, those with a final pathologic exam corresponding to pT4 tumors.
A national multicenter retrospective cohort study is proposed. Given that the objectives of the study is to establish the prognostic oncologic impact of developing metachronous peritoneal carcinomatosis, it is intended to include patients who have completed three years of follow-up, therefore, the period of inclusion of patients to be analyzed is from 2015 to 2017.
Inclusion criteria:
- Patients operated on for colon cancer, considering those patients with neoplasia located from 15 cm from the anal margin in the proximal direction.
- Patients with histological confirmation of colon adenocarcinoma.
- Postoperative anatomical-pathological staging pT4a and pT4b.
- Patients operated both electively and urgently.
- Patients in whom a complete macroscopic resection of the primary tumor is achieved.
Exclusion criteria:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon cancer above 15 cm from anal verge
- •Curative intent surgery
- •Pathologic confirmation of pT4 adenocarcinoma
排除标准
- •R2 cancer resection
- •Inclusion in other randomized clinical trials
- •Pathologic diagnosis of colon cancer other than adenocarcinoma, such as GIST, leiomyosarcomas, neuroendocrine tumors, or other types even more unusual.
结局指标
主要结局
Metachronous peritoneal carcinomatosis
时间窗: A minimum of 3-years follow-up
Number of patients diagnosed with peritoneal carcinomatosis during regular oncologic follow-up
次要结局
- Time to metachronous peritoneal carcinomatosis diagnosis(A minimum of 3-years follow-up)
研究者
Carlos Cerdán Santacruz
Consultant. Colorectal Surgery Department. Principal Investigator
Hospital San Carlos, Madrid