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Prediction of Chemotherapy Toxicity and Survival in Elderly Cancer Patients by CARG Score

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05432726
Enrollment
63
Registered
2022-06-27
Start date
2022-07-20
Completion date
2025-07-01
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors ,Adults

Keywords

CARG score - Elderly

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.

Interventions

OTHERcalculating CARG score

Before the initiation of chemotherapy, study participants will complete the GA questions included in the CARG toxicity score. Total risk score will be calculated ranging from 0 (lowest toxicity risk) to 19 (highest toxicity risk), incorporates measures of functional status such as fall history, hearing problems, physical capabilities, performance status as well as objective measures including age, gender, height, weight, cancer type, type and dose of chemotherapy, hemoglobin, and creatinine clearance. CARG score will be stratified as low (score 0-5), intermediate (score 6-9) and high risk (score 10-19). Chemotherapy-related toxicities will be assessed and graded as per the NCI-CTCAE, version 5.0. Hospitalizations due to AEs during first-line chemotherapy will be collected. Subsequent changes in chemotherapy dosage, treatment delays, and treatment discontinuation due to adverse effects as well as mortality rate after treatment will also be monitored.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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).6 months follow up in first line chemotherapy in the advanced setting

Secondary

MeasureTime frameDescription
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 PFS (progression free survival).2 yearsit will be measured from the time from start of first-line chemotherapy to disease progression or, censored at last clinic visit)
Correlation between the CARG score and 2 year OS (overall survival).2 yearsit will be measured from the start of chemotherapy to death or censored at the last clinic visit

Contacts

Primary ContactDonia H. Abd EL Hameed, master
donia.hussein@med.aun.edu.eg01069711755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026