Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases Versus Chemotherapy Alone
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.
详细描述
The present study is a single-center retrospective observational cohort study with a propensity score matching. Between 2016 and 2022 from our institutional database minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases will be selected. Patients will be divided into two groups:
- Surgical resection of the primary tumour before to systemic therapy
- Systemic therapy without previous resection of the primary tumour. Propensity score matching (PSM) will be performed, to minimize the selection bias by adjusting variables that may affect the survival of patients. Categorical variables will be compared using the chi-square test or Fisher's exact test. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test. Survival rate will be determined by using Kaplan-Meier analysis with a log-rank test. Univariate and multivariate analyses for survival will be conducted using Cox proportional hazard models. Statistical results will be considered significant at p values less than 0.05.
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
- •Histologically confirmed colorectal adenocarcinoma
- •Resectable minimally symptomatic primary tumor with unresectable synchronous metastasis
- •Age ≥ 18 years
- •Informed consent
排除标准
- •Synchronous cancers
- •Carcinomatosis
- •Prior surgery, chemotherapy, radiation therapy for the primary tumor or distant metastases
研究组 & 干预措施
Primary tumour resection group.
Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.
干预措施: surgery of the primary tumour (Procedure)
Primary tumour resection group.
Surgical resection of the primary tumour followed by chemotherapy +/- targeted therapy regime.
干预措施: chemotherapy (Drug)
Chemotherapy group.
Chemotherapy +/- targeted therapy alone.
干预措施: chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: 3 years
次要结局
- Thirty-day mortality(30 days)
- Progression free survival (PFS)(3 years)
- Rate of surgical intervention due to complication of treatment(1 year)