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TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer
Sponsor: The University of Hong Kong
Summary
Older adults receiving systemic cancer treatments are at increased risk of developing severe treatment-related toxicities (TRT). Existing prediction tools such as CARG and CRASH have limited applicability in Chinese populations and do not fully address toxicities associated with newer therapies, including immunotherapy and targeted agents. The Treatment-related Toxicity Risk Model (TRTRM) was recently developed and validated in Hong Kong using data from 700 older cancer patients and has demonstrated better predictive accuracy and clinical relevance compared with existing tools. This multi-center, open-label, randomized controlled trial aims to evaluate the clinical utility of the TRTRM by guiding treatment dose intensity and monitoring strategies. Participants aged 65 years or older who are starting a new systemic anti-cancer treatment will be randomized in a 1:1 ratio to receive either usual care or TRTRM-informed care. In the intervention arm, patients identified as having intermediate or high risk of toxicity will receive a "start-low, go-slow" dosing strategy with close monitoring, while low-risk patients will receive standard dosing. The primary outcome is the incidence of grade 3 or higher treatment-related toxicities within the first two months of treatment initiation. Secondary outcomes include emergency visits, unplanned hospitalizations, premature treatment termination, early mortality, quality of life, and overall survival.
Official title: Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-05-01
Completion Date
2030-07-31
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
TRTRM-guided risk-stratified treatment strategy
The Treatment-Related Toxicity Risk Model (TRTRM/ACTTOP) is used prospectively as a clinical decision-support tool to guide treatment dosing and monitoring in older patients starting systemic anti-cancer therapy. The TRTRM/ACTTOP stratifies patients into low-, intermediate-, or high-risk categories for severe treatment-related toxicities. Dose modification based on TRTRM risk category applies only to patients receiving chemotherapy. Low-risk patients receive 80% to full-dose chemotherapy. Intermediate- or high-risk patients starting chemotherapy begin treatment at 60% dose intensity using a "start-low, go-slow" strategy, with dose escalation based on tolerance. Patients receiving targeted therapy or immunotherapy follow standard local dosing protocols without TRTRM/ACTTOP-guided dose modification. Intermediate- and high-risk patients receive weekly monitoring by healthcare professionals during the initial treatment period.
Locations (1)
Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR
Hong Kong, Hong Kong