Cancer (Solid Tumors)NCT07484932
TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer
A study testing TRTRM-guided risk-stratified treatment strategy in people with Cancer (Solid Tumors) and Geriatric Oncology, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer (Solid Tumors), Geriatric Oncology
- What is being tested?
- TRTRM-guided risk-stratified treatment strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 May 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- Agreement for treatment according to the TRTRM (ACTTOP) -risk strategy if in the TRTRM (ACTTOP) -informed care group
- Fluent in English or Chinese
- 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.
Who cannot join
- 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
- Dementia or patient mentally not fit for consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR
Hong Kong
Wing Lok Chan, (852) 2255-3111, winglok@hku.hk
About this study
Official title: Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ ACTTOP) in Older Patients With Cancer: a Randomised Controlled 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.
Read the detailed description
This is a multi-center, open-label, prospective, randomized controlled trial designed to assess the clinical utility of the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP) in reducing severe treatment-related toxicities in older patients with cancer undergoing systemic anti-cancer therapy.
Participants aged 65 years or older who are scheduled to start a new systemic anti-cancer treatment, including chemotherapy, targeted therapy, or immunotherapy, will be recruited from outpatient oncology clinics at four public hospitals in Hong Kong. Eligible participants will be randomized in a 1:1 ratio to either a usual care group or a TRTRM (ACTTOP) -informed care group using a computer-generated block randomization scheme, stratified by treatment type (chemotherapy-containing versus non-chemotherapy-containing regimens) and treatment intent (radical versus palliative).
In the usual care group, treating oncologists will manage patients according to standard clinical practice without access to the TRTRM (ACTTOP) score. In the TRTRM-informed care group, the TRTRM (ACTTOP) score will be calculated prior to treatment initiation and used to guide treatment decisions. Patients classified as low risk will receive 80% to full standard dose. Patients classified as intermediate or high risk who are receiving chemotherapy will start treatment at 60% dose intensity, with dose escalation based on treatment tolerance. Patients receiving targeted therapy or immunotherapy will receive standard dosing according to local protocols. Intermediate- and high-risk patients will also receive weekly monitoring by healthcare professionals via telephone or remote systems during the initial treatment period.
The primary endpoint is the 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 within the first two months of treatment initiation. Secondary endpoints include emergency visits and unplanned hospitalizations due to treatment-related toxicities, premature treatment termination, early mortality within three months, changes in quality of life measured by the EORTC QLQ-C30 Global Health Status scale, and overall survival.
- Conditions
- Cancer (Solid Tumors), Geriatric Oncology
- Being tested
- TRTRM-guided risk-stratified treatment strategy
- Keywords
- toxicities, prediction model, ACTTOP, Older patients, geriatrics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRTRM-guided risk-stratified treatment strategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants in the usual care arm receive standard physician-determined systemic anti-cancer treatment. Treatment dose intensity and monitoring are determined by the treating clinician according to routine clinical practice without access to the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP). |
| Intervention group (TRTRM-informed care) | Experimental | Participants in the TRTRM (ACTTOP) -informed care arm receive systemic anti-cancer treatment guided by the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP). The TRTRM (ACTTOP) is used to stratify patients into low-, intermediate-, or high-risk categories for severe treatment-related toxicities and to guide treatment dose intensity and monitoring strategies.
Treatment dose intensity is guided by TRTRM (ACTTOP) risk category. Patients classified as low risk receive 80% to full-dose chemotherapy. Patients classified as intermediate or high risk who are starting chemotherapy begin treatment at 60% dose intensity using a "start-low, go-slow" escalation strategy based on treatment tolerance. Patients receiving targeted therapy or immunotherapy follow local dosing protocols.
Intermediate- and high-risk patients receive weekly monitoring by healthcare professionals via telephone or a remote monitoring system. Receives: Other: TRTRM-guided risk-stratified treatment strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months after treatment initiation
Secondary outcomes (6)
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.
Measured: 2 months after treatment initiation
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.
Measured: 2 months after treatment initiation
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.
Measured: Within 2 months of treatment initiation
Early Mortality
Death occurring within three months of starting systemic anti-cancer treatment.
Measured: Within 3 months of treatment initiation
Change in Quality of Life
Change in health-related quality of life measured using the Global Health Status scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The Global Health Status scale consists of two items assessing overall health and overall quality of life, each rated on a 7-point scale from 1 (very poor) to 7 (excellent). Raw scores are transformed to a 0-100 scale according to EORTC scoring guidelines, with higher scores indicating better overall health-related quality of life.
Measured: Baseline to 2 months after treatment initiation
Overall Survival
Time from treatment initiation to death from any cause.
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start4 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (Solid Tumors)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a two-arm, parallel-group randomized design to evaluate the clinical utility of the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP) in older adults starting systemic anti-cancer therapy. Participants are randomized in a 1:1 ratio to receive either TRTRM (ACTTOP)-informed care or usual care and remain in their assigned group throughout the study. Randomization is performed using a computer-generated block randomization scheme and is stratified by treatment type (chemotherapy-containing versus non-chemotherapy-containing regimens) and treatment intent (radical versus palliative). There is no crossover between study arms. In the intervention arm, clinicians use TRTRM (ACTTOP) risk categories to guide initial dose intensity and monitoring, applying a "start-low, go-slow" strategy for intermediate- and high-risk patients receiving chemotherapy. Usual care follows physician-determined dosing without access to the TRTRM (ACTTOP).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wing Lok Wendy Chan, The University of Hong Kong
- Investigators
- Wing-Lok Wendy Chan, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484932
- Sponsor's protocol ID
- CIRB-2025-629-1
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because data sharing was not approved by the Institutional Review Board and was not included in the informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07484932
- Acronym / sponsor ID
- CIRB-2025-629-1
- Conditions
- Cancer (Solid Tumors), Geriatric Oncology
- Keywords
- toxicities, prediction model, ACTTOP, Older patients, geriatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, open-label, prospective, randomized controlled trial designed to assess the clinical utility of the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP) in reducing severe treatment-related toxicities in older patients with cancer undergoing systemic anti-cancer therapy.
Participants aged 65 years or older who are scheduled to start a new systemic anti-cancer treatment, including chemotherapy, targeted therapy, or immunotherapy, will be recruited from outpatient oncology clinics at four public hospitals in Hong Kong. Eligible participants will be randomized in a 1:1 ratio to either a usual care group or a TRTRM (ACTTOP) -informed care group using a computer-generated block randomization scheme, stratified by treatment type (chemotherapy-containing versus non-chemotherapy-containing regimens) and treatment intent (radical versus palliative).
In the usual care group, treating oncologists will manage patients according to standard clinical practice without access to the TRTRM (ACTTOP) score. In the TRTRM-informed care group, the TRTRM (ACTTOP) score will be calculated prior to treatment initiation and used to guide treatment decisions. Patients classified as low risk will receive 80% to full standard dose. Patients classified as intermediate or high risk who are receiving chemotherapy will start treatment at 60% dose intensity, with dose escalation based on treatment tolerance. Patients receiving targeted therapy or immunotherapy will receive standard dosing according to local protocols. Intermediate- and high-risk patients will also receive weekly monitoring by healthcare professionals via telephone or remote systems during the initial treatment period.
The primary endpoint is the 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 within the first two months of treatment initiation. Secondary endpoints include emergency visits and unplanned hospitalizations due to treatment-related toxicities, premature treatment termination, early mortality within three months, changes in quality of life measured by the EORTC QLQ-C30 Global Health Status scale, and overall survival.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a two-arm, parallel-group randomized design to evaluate the clinical utility of the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP) in older adults starting systemic anti-cancer therapy. Participants are randomized in a 1:1 ratio to receive either TRTRM (ACTTOP)-informed care or usual care and remain in their assigned group throughout the study. Randomization is performed using a computer-generated block randomization scheme and is stratified by treatment type (chemotherapy-containing versus non-chemotherapy-containing regimens) and treatment intent (radical versus palliative). There is no crossover between study arms. In the intervention arm, clinicians use TRTRM (ACTTOP) risk categories to guide initial dose intensity and monitoring, applying a "start-low, go-slow" strategy for intermediate- and high-risk patients receiving chemotherapy. Usual care follows physician-determined dosing without access to the TRTRM (ACTTOP).
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants in the usual care arm receive standard physician-determined systemic anti-cancer treatment. Treatment dose intensity and monitoring are determined by the treating clinician according to routine clinical practice without access to the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP). |
| Intervention group (TRTRM-informed care) | Experimental | Other: TRTRM-guided risk-stratified treatment strategyParticipants in the TRTRM (ACTTOP) -informed care arm receive systemic anti-cancer treatment guided by the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP). The TRTRM (ACTTOP) is used to stratify patients into low-, intermediate-, or high-risk categories for severe treatment-related toxicities and to guide treatment dose intensity and monitoring strategies. Treatment dose intensity is guided by TRTRM (ACTTOP) risk category. Patients classified as low risk receive 80% to full-dose chemotherapy. Patients classified as intermediate or high risk who are starting chemotherapy begin treatment at 60% dose intensity using a "start-low, go-slow" escalation strategy based on treatment tolerance. Patients receiving targeted therapy or immunotherapy follow local dosing protocols. Intermediate- and high-risk patients receive weekly monitoring by healthcare professionals via telephone or a remote monitoring system. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
- Agreement for treatment according to the TRTRM (ACTTOP) -risk strategy if in the TRTRM (ACTTOP) -informed care group
Key exclusion criteria (5 listed)
- 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
- Dementia or patient mentally not fit for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRTRM-guided risk-stratified treatment strategyThe 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. | Other | Intervention group (TRTRM-informed care) |
Primary outcome
Incidence of Grade 3 or Higher Treatment-Related Toxicities
Time frame: 2 months after treatment initiation
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.
6 secondary outcomes
Number of Participants with Emergency Department Visits Due to Treatment-Related Toxicities
Time frame: 2 months after treatment initiation
Number of Participants with Unplanned Hospitalizations Due to Treatment-Related Toxicities
Time frame: 2 months after treatment initiation
Number of Participants with Premature Termination of Systemic Anti-Cancer Treatment Due to Treatment-Related Toxicities
Time frame: Within 2 months of treatment initiation
Early Mortality
Time frame: Within 3 months of treatment initiation
Change in Quality of Life
Time frame: Baseline to 2 months after treatment initiation
Overall Survival
Time frame: Baseline to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Additional study information is available at the HKU Clinical Trials RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing was not approved by the Institutional Review Board and was not included in the informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wing-Lok Wendy Chan, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRTRM-guided risk-stratified treatment strategy in people with Cancer (Solid Tumors) and Geriatric Oncology, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wing-Lok Wendy Chan, MBBS (852-22553111 ext. 5124, winglok@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3 or Higher Treatment-Related Toxicities (time frame: 2 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.