Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:05 AM
Study NCT ID:
NCT07484932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: