Predictors of Disease Recurrence After Curative Surgery for Stage I Colon Cancer - CORE1 (COlon Cancer REcurrence in Stage 1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 24
- 主要终点
- Recurrence
研究概览
简要总结
Patients with stage I (pT1-2 N0 M0) colon cancer (CC) accounts for 15-20% of colonic neoplasia. Stage I CC is mostly cured with surgical resection, consequently, adjuvant chemotherapy is never considered for this subset of patients. Moreover, some international guidelines, including NCCN guidelines, recommend less intensive follow-up 1. However, around 5% of patients with stage I CC will develop a recurrence within 5 years from surgery. Despite the very good prognosis usually attributed to this stage (5-years relapse-free survival: 95%), some clinical and pathological factors beyond the standard AJCC staging may be associated with worse clinical features and may aid in prognostic stratification. Although some authors investigated the role of pathological and clinical factors in patients with stage II and III disease, only few data are available for patients with stage I CC1.
The present multicentric retrospective study aims to:
- Assess the actual incidence of recurrence in a large cohort of patients with stage I CC undergone curative resection.
- Investigate the clinical and pathological characteristics of patients who developed a recurrence, with the aim of identifying those associated with a significantly increased risk.
- Analyze the pattern of recurrence.
- Analyze survival after recurrence.
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
- •Age ≥ 18 years
- •Colon cancer up to recto-sigmoid junction
- •Histological diagnosis of adenocarcinoma
- •pT1 or pT2 according to AJCC staging system
- •Urgent and elective surgery
- •Curative resection
- •Minimally invasive or open surgery
- •Completion surgery included (Surgery for endoscopically resected pT1)
排除标准
- •Rectal cancer
- •Adenoma with low- or high-grade dysplasia
- •Histology other than adenocarcinoma (i.e., lymphoma, neuroendocrine tumor, squamous carcinoma, etc)
- •Neo-adjuvant chemotherapy or radiotherapy
- •History of tumors other than CC
结局指标
主要结局
Recurrence
时间窗: 5 years
Number of patients who relapsed after curative resection
次要结局
- Overall survival(5 years)
- Cancer-related survival(5 years)