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Clinical Trials/NCT05432726
NCT05432726
Not yet recruiting
Not Applicable

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

Assiut University0 sites63 target enrollmentJuly 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Solid Tumors ,Adults
Sponsor
Assiut University
Enrollment
63
Primary Endpoint
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).
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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. The CARG score uses 5 key geriatric assessment (GA) domains, selected laboratory test values, age, tumor type, and treatment intensity to categorize patients into 3 risk groups for severe chemotherapy toxicity (grade 3-5): low risk (score 0-5; 30% grade 3-5 toxicity), medium risk (score 6-9; 52%), or high risk (score ≥10; 83%). The CARG risk score has been validated in other countries and in specific tumour sites to varying degrees. It is included in ASCO Guideline and NCCN guidelines for Geriatric Oncology to predict severe chemotherapy-related toxicity. However its applicability in Egyptian patients is unknown as geriatric assessment is not routinely used for elderly patients. The investigators may provide an evidence for validating the CARG risk score in Elderly patients with advanced solid tumors receiving systemic chemotherapy.

Registry
clinicaltrials.gov
Start Date
July 20, 2022
End Date
July 1, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Donia Hussein Abd Elhamed

Assistant Lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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).

Time Frame: 6 months follow up in first line chemotherapy in the advanced setting

Secondary Outcomes

  • 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)

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