TRTRM (ACTTOP) Guided Dosing in Older Cancer Patients
Official title: Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial
Run by The University of Hong Kong · NCT07484932 · Data updated 2026-11-12
Aims to see if using the TRTRM risk score can help tailor cancer treatment doses for people 65 and older to reduce serious treatment-related toxicities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | May 4, 2026 |
| Main results expected | December 31, 2029 |
| Study ends | July 31, 2030 |
| Registry record updated | May 20, 2026 |
| Trial ID | NCT07484932 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Older adults (65+) with solid tumors (lung, gastrointestinal, breast, prostate, or uterine cancer) scheduled to start a new systemic anti-cancer therapy and ECOG 0-2.
✕Probably not a fit
Patients who do not experience toxicity risk differences or who are not candidates for dose modification may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center, open-label, randomized trial enrolling patients aged 65 or older who are starting a new systemic cancer treatment. Participants are randomized to usual care versus TRTRM-guided care, with dose intensity adjusted by risk level: low risk may receive 80% to full dose, while intermediate/high risk on chemotherapy starts at 60% with possible dose increases based on tolerance; targeted therapy and immunotherapy follow standard practices. The TRTRM (ACTTOP) score is calculated before treatment and used to guide decisions. The study uses stratified randomization by treatment type and intent and is conducted at four public hospitals in Hong Kong. Primary goal is to reduce severe treatment-related toxicities and improve treatment feasibility in older populations.
Why it matters
Potential benefit: If successful, TRTRM-guided dosing could reduce toxicities and allow safer, more effective cancer treatment in older adults.
How similar studies have gone: Prior work in Hong Kong showed TRTRM/ACTTOP has better predictive accuracy than existing tools, but this trial tests clinical utility in dose decisions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 65 or above 2. A diagnosis of lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, and uterine cancer with histological confirmation or radiological diagnosis\*\* 3. Seen by the oncologist and scheduled to receive a new systemic anti-cancer treatment, including chemotherapy, targeted therapy, and immunotherapy, in either radical or first/second-line palliative intent. The planned treatment regimen is expected to last for at least 3 months. 4. ECOG performance status of 0-2 5. Agreement for treatment according to the TRTRM (ACTTOP) -risk strategy if in the TRTRM (ACTTOP) -informed care group 6. Fluent in English or Chinese 7. Valid consent obtained \*\* Only these five types of cancer are included to reduce the heterogeneity of the patients, as they are the top 5 cancers in Hong Kong. Exclusion Criteria: 1. Planned for radiotherapy alone 2. Planned for systemic treatment concomitant with radiotherapy 3. Scheduled to have hormonal therapy alone e.g. tamoxifen, aromatase inhibitors, luteinizing hormone-releasing hormone agonist (LHRHa) 4. Planned for surgery within 3 months 5. Dementia or patient mentally not fit for consent
Where it's running
-
Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR
Hong Kong, Hong Kong Recruiting
Study contacts
- Principal investigator: Wing-Lok Wendy Chan, MBBS — The University of Hong Kong
- Study coordinator: Wing-Lok Wendy Chan, MBBS
- Email: winglok@hku.hk
- Phone: 852-22553111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.