TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe University of Hong Kong
About this trial
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
This trial does not accept healthy volunteersQualifiers
Aged 65 or above
A diagnosis of lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, and uterine cancer with histological confirmation or radiological diagnosis**
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.
ECOG performance status of 0-2
Disqualifiers
Planned for radiotherapy alone
Planned for systemic treatment concomitant with radiotherapy
Scheduled to have hormonal therapy alone e.g. tamoxifen, aromatase inhibitors, luteinizing hormone-releasing hormone agonist (LHRHa)
Planned for surgery within 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
TRTRM-guided risk-stratified treatment strategy
Other interventionThe 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Usual careNo intervention 0 interventions
Group B: Intervention group (TRTRM-informed care)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Grade 3 or Higher Treatment-Related Toxicities
Incidence of grade 3 or higher treatment-related toxicities as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
2 months after treatment initiationSecondary outcomes
1
Number of Participants with Emergency Department Visits Due to Treatment-Related Toxicities
Number of participants who experience one or more unplanned emergency department visits attributed to treatment-related toxicities, determined through review of clinical records.
Time frame
2 months after treatment initiation2
Number of Participants with Unplanned Hospitalizations Due to Treatment-Related Toxicities
Number of participants who experience one or more unplanned hospitalizations attributable to treatment-related toxicities, identified through review of electronic medical records.
Time frame
2 months after treatment initiation3
Number of Participants with Premature Termination of Systemic Anti-Cancer Treatment Due to Treatment-Related Toxicities
Premature termination of systemic anti-cancer treatment due to treatment-related toxicities, defined as inability to complete all planned cycles in the adjuvant setting or the first four cycles in the palliative setting. Treatment discontinuation will be verified via clinical records.
Time frame
Within 2 months of treatment initiation4
Early Mortality
Death occurring within three months of starting systemic anti-cancer treatment.
Time frame
Within 3 months of treatment initiationSponsors and contacts
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Source ClinicalTrials.gov