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临床试验/NCT05432726
NCT05432726尚未招募不适用

Prediction of Chemotherapy Toxicity and Survival in Elderly Cancer Patients by Using CARG Score (Cancer and Aging Research Group Score)

Assiut University0 个研究点目标入组 63 人开始时间: 2022年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
63
主要终点
Prediction of grade 3-5 chemotherapy toxicity risk in elderly patients (aged ≥65 years old) with advanced solid tumors by measurement of CARG risk score (Cancer and Aging Research Group).

研究概览

简要总结

Prediction of chemotherapy toxicity and survival in elderly (aged ≥65 years old) patients with advanced solid tumors receiving systemic chemotherapy by using CARG risk score.

详细描述

Elderly patients (age ≥65 years) with cancer represent a growing proportion of patients in oncology clinical practice, primarily due to increasing life-spans as well as medical progress contributing to decreased morbidity and mortality from other causes.

Treatment decision-making for elderly patients with advanced cancer is often more complex than decision-making in younger cancer patients. The elderly population is heterogeneous in terms of their overall health status beyond their cancer diagnosis.

The risk of severe chemotherapy toxicity is one of the most important factors oncologists consider when recommending a treatment plan, and in elderly patients with advanced cancers, 25% to 60% of patients are treated with a planned dose reduction for their first chemotherapy cycle. These dose reductions are usually made on the basis of chronologic age and ECOG performance status, variables well known to be poor predictors of chemotherapy toxicity risk and tolerability of treatment.

Clinical prediction tools provide physicians with more accurate means for identifying patients who are at low or high risk of adverse outcomes.

The cancer Aging Research Group (CARG) risk score, developed by Hurria and colleagues, is a validated geriatric assessment tool that predicts for significant chemotherapy-related toxicities (grades 3-5) in older North American adults aged ≥65 years starting on chemotherapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥65 years.
  • Sex: male, female.
  • ECOG performance status 0,1,2
  • Type of malignancy: solid tumor malignancies planned for systemic chemotherapy alone.
  • Stage: Advanced stage (metastatic first line, recurrent, unresectable locally advanced).
  • Type of Systemic therapy: chemotherapy alone not combined with immunotherapy or radiotherapy.
  • Able to comprehend and complete questionnaire.

排除标准

  • Receiving concurrent radiotherapy or immunotherapy.
  • ECOG performance status >2.

结局指标

主要结局

Prediction of grade 3-5 chemotherapy toxicity risk in elderly patients (aged ≥65 years old) with advanced solid tumors by measurement of CARG risk score (Cancer and Aging Research Group).

时间窗: 6 months follow up in first line chemotherapy in the advanced setting

次要结局

  • Correlation of the physician measured ECOG PS with grade 3-5 toxicities.(6 months follow up in first line chemotherapy in the advanced setting)
  • Correlation between the CARG score and 2 year OS (overall survival).(2 years)
  • Correlation between the CARG score and 2 year PFS (progression free survival).(2 years)

研究者

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

Donia Hussein Abd Elhamed

Assistant Lecturer

Assiut University

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