Clinical trial NCT05432726: Prediction of Chemotherapy Toxicity and Survival in Elderly Cancer Patients by CARG Score
Official title: Prediction of Chemotherapy Toxicity and Survival in Elderly Cancer Patients by Using CARG Score (Cancer and Aging Research Group Score)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solid Tumors ,Adults
Keywords: CARG score - Elderly
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 63
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients (aged ≥65 year's old) planned to receive first-line chemotherapy for advanced solid tumor malignancies, presenting to the clinical oncology department, Assiut University Hospitals, Assiut, Egypt, from june 2022 to june 2023.

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.

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.

Primary outcomes:
measure: 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).
timeFrame: 6 months follow up in first line chemotherapy in the advanced setting
Secondary outcomes:
measure: Correlation of the physician measured ECOG PS with grade 3-5 toxicities.
timeFrame: 6 months follow up in first line chemotherapy in the advanced setting
measure: Correlation between the CARG score and 2 year PFS (progression free survival).
timeFrame: 2 years
measure: Correlation between the CARG score and 2 year OS (overall survival).
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Moth EB, Kiely BE, Stefanic N, Naganathan V, Martin A, Grimison P, Stockler MR, Beale P, Blinman P. Oncologists' perceptions on the usefulness of geriatric assessment measures and the CARG toxicity score when prescribing chemotherapy for older patients with cancer. J Geriatr Oncol. 2019 Mar;10(2):210-215. doi: 10.1016/j.jgo.2018.11.004. Epub 2018 Nov 28.
citation: Ortland I, Mendel Ott M, Kowar M, Sippel C, Jaehde U, Jacobs AH, Ko YD. Comparing the performance of the CARG and the CRASH score for predicting toxicity in older patients with cancer. J Geriatr Oncol. 2020 Jul;11(6):997-1005. doi: 10.1016/j.jgo.2019.12.016. Epub 2020 Jan 9.
citation: Nishijima TF, Deal AM, Williams GR, Sanoff HK, Nyrop KA, Muss HB. Impact of the Cancer and Aging Research Group score and treatment intensity on survival and toxicity outcomes in older adults with advanced noncolorectal gastrointestinal cancers. Cancer. 2022 May 15;128(10):1929-1936. doi: 10.1002/cncr.34135. Epub 2022 Feb 11.
citation: DuMontier C, Sedrak MS, Soo WK, Kenis C, Williams GR, Haase K, Harneshaug M, Mian H, Loh KP, Rostoft S, Dale W, Cohen HJ. Arti Hurria and the progress in integrating the geriatric assessment into oncology: Young International Society of Geriatric Oncology review paper. J Geriatr Oncol. 2020 Mar;11(2):203-211. doi: 10.1016/j.jgo.2019.08.005. Epub 2019 Aug 23.