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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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