NCT07484932 TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer
| NCT ID | NCT07484932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Cancer (Solid Tumors) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2026-05-04 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Wing-Lok Wendy Chan, MBBS
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT07484932 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cancer (Solid Tumors). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07484932 currently recruiting?
Yes, NCT07484932 is actively recruiting participants. Contact the research team at winglok@hku.hk for enrollment information.
Where is the NCT07484932 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07484932 clinical trial?
NCT07484932 is sponsored by The University of Hong Kong. The principal investigator is Wing-Lok Wendy Chan, MBBS at The University of Hong Kong. The trial plans to enroll 400 participants.
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