跳至主要内容
临床试验/NCT04543019
NCT04543019Unknown不适用

Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer Patients as Predictive Factors for Systemic Therapy Outcome

Assiut University0 个研究点目标入组 50 人开始时间: 2020年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Progression free survival (PFS) and overall survival (OS)

研究概览

简要总结

To determine progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer in relation to age, BMI and tumor sidedness, describing their predictive influence on systemic therapy outcome.

详细描述

Colorectal cancer (CRC) represents a major public health concern as it is the third most frequently diagnosed cancer and the fourth cause of cancer-related mortality worldwide . The five-year survival rate is around 64.9% for all stages, while in metastatic cases, it only reaches 13.1% .

Approximately 26% of CRCs are diagnosed at stage IV among patients aged younger than 50 years, compared with 23% in those aged 50 to 64 years and 19% among those aged 65 years and older. Overall survival (OS) among patients younger than 50 years (68%) is similar to that in those 50 to 64 years (69%) because of a later stage at diagnosis.

Obesity is associated with an increased incidence of CRC . In recent studies body mass index (BMI) was prognostic for overall survival and progression free survival. That is risk of progression and/or death was greatest for low BMI; risk decreased as BMI increased. BMI was not predictive of treatment effect . Cachexia and associated poor performance status have previously been identified as negative prognostic factors in patients with CRC.

Tumor sidedness is an independent prognostic factor in patients with early and metastatic CRC as left-sided primaries have improved outcomes. sidedness also represents a powerful predictor of benefit from anti epidermal growth factor receptor[EGFR] inhibitors therapies in patients with RAS wild-type metastatic CRC (mCRC) .

The mainstay of treatment of mCRC includes cytotoxic chemotherapy with the addition of a molecularly targeted agent . The cytotoxic regimens that are usually used include a combination of oxaliplatin or irinotecan with a fluoropyrimidine, in addition to targeted agents such as [EGFR] inhibitors for patients with RAS wild-type mCRC or vascular endothelial growth factor inhibitors .

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years.
  • Pathologically proven colon or rectal adenocarcinoma.
  • Stage IV colorectal cancer.

排除标准

  • Age <18 years.
  • Not pathologically proven colon or rectal adenocarcinoma.
  • Stage I, II and III colorectal cancer.

结局指标

主要结局

Progression free survival (PFS) and overall survival (OS)

时间窗: between January 2015 and December 2019

Progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer patients in correlation to age, BMI and tumor sidedness.

次要结局

  • response to systemic therapy(between January 2015 and December 2019)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gehad Ahmed Abd El-Razik

principal investigator

Assiut University

相似试验