Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial

What this Trial Is About

Researchers are evaluating the Treatment-Related Toxicity Risk Model (TRTRM/ACTTOP) in older adults aged 65 and above who are starting new systemic cancer treatments. This trial aims to address the increased risk of severe treatment-related toxicities in this population and improve prediction tools that are more relevant to Chinese patients. The study compares usual care with care guided by the TRTRM model to see if it can better reduce severe toxicities during cancer treatment. Participants are randomly assigned to one of two groups: usual care or TRTRM-informed care. In the TRTRM-informed group, patients are classified by their risk of toxicity, and dosing strategies are adjusted accordingly. Low-risk patients receive 80% to full standard dose chemotherapy, while intermediate- and high-risk patients starting chemotherapy begin at 60% dose intensity with gradual dose escalation. Those receiving targeted therapy or immunotherapy follow standard dosing. Patients at intermediate or high risk also receive weekly monitoring via telephone or remote systems during the initial treatment period. During the study, participants have their treatment-related toxicities closely tracked, especially severe cases within the first two months. Researchers also monitor emergency visits, unplanned hospitalizations, early treatment stopping, mortality within three months, quality of life changes, and overall survival up to two years. Treatment tolerance and safety are carefully observed through regular assessments and follow-ups, with total participation lasting up to two years for survival tracking.

TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer