Integrating Geriatric 8 (G8) Screening and Cancer and Age Research Group (CARG) Toxicity Assessment Score Into Routine Care for Older Adults With Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorAssiut University

About this trial

This study evaluates whether using specialized geriatric screening and toxicity prediction tools can help oncologists personalize chemotherapy dosing and reduce severe side effects in older adults with solid cancers.

Older adults with cancer have diverse levels of physical resilience and functional reserve that standard oncologic performance scores often miss. Consequently, uniform standard chemotherapy dosing can lead to severe, life-threatening toxicities, unplanned hospitalizations, or early treatment discontinuation.

In this prospective-retrospective comparative study, patients aged 65 years and older who are starting chemotherapy are prospectively evaluated using the Geriatric 8 (G8) screening tool. Patients identified as vulnerable (G8 score ≤ 14) undergo a Comprehensive Geriatric Assessment (CGA) across functional, nutritional, cognitive, and psychological domains. In addition, all prospective participants are evaluated using the Cancer and Age Research Group (CARG) toxicity tool to calculate their risk of severe side effects. Chemotherapy doses are risk-adapted based on CARG scores:

* Low Risk: Standard chemotherapy dose * Intermediate Risk: 20% dose reduction * High Risk: 50% dose reduction

Participants are followed every 3 months for 1 year to evaluate treatment tolerance, adherence, tumor response, and survival. These outcomes will be compared against a historical retrospective cohort of older patients with solid tumors who received standard-dose chemotherapy without G8 screening or CARG toxicity risk stratification.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 65 years or older

Confirmed diagnosis of any solid malignancy

Scheduled to initiate cytotoxic chemotherapy

Disqualifiers

Hematological malignancies (e.g., leukemia, lymphoma)

Treatment plans consisting exclusively of non-chemotherapy modalities (e.g., endocrine therapy, immunotherapy monotherapy, or radiotherapy alone)

Incomplete or missing medical records (applicable to the retrospective historical control cohort)

Trial population

Older adult patients (aged 65 years and older) with confirmed solid malignancies who are scheduled to initiate chemotherapy at the Clinical Oncology Department, Assiut University Hospitals, Faculty of Medicine. The population comprises prospectively presenting patients undergoing oncogeriatric screening and risk-adapted chemotherapy, alongside a historical control cohort of comparable older patients previously treated at the same center.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Prospective G8/CARG-Guided Cohort
Group B: Retrospective Historical Control Cohort

Trial outcomes

Primary outcomes

1

Percentage of Participants With Grade 3 to 5 Chemotherapy-Related Toxicities

Percentage of participants who experience at least one severe, life-threatening, or fatal (Grade 3, 4, or 5) adverse event related to chemotherapy. Toxicities are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria.

Time frame
Up to 12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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