TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer

NCT07484932 | Recruiting

• 1 other identifier: CIRB-2025-629-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer (Solid Tumors); Geriatric Oncology

Keywords

toxicities; prediction model; ACTTOP; Older patients; geriatrics

Outcome Measures

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.

  2 months after treatment initiation

Secondary Outcomes (6)

• Number of Participants with Emergency Department Visits Due to Treatment-Related Toxicities

  2 months after treatment initiation

• Number of Participants with Unplanned Hospitalizations Due to Treatment-Related Toxicities

  2 months after treatment initiation

• Number of Participants with Premature Termination of Systemic Anti-Cancer Treatment Due to Treatment-Related Toxicities

  Within 2 months of treatment initiation

• Early Mortality

  Within 3 months of treatment initiation

• Change in Quality of Life

  Baseline to 2 months after treatment initiation

Study Arms (2)

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.

Other: TRTRM-guided risk-stratified treatment strategy

Interventions

TRTRM-guided risk-stratified treatment strategy OTHER

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.

Intervention group (TRTRM-informed care)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Related Links

• Additional study information is available at the HKU Clinical Trials Registry

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wing-Lok Wendy Chan, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing-Lok Wendy Chan, MBBS

CONTACT

852-22553111; winglok@hku.hk

Horace Shek, BSc

CONTACT

852-22553111; oncology@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is open-label to participants and treating clinicians due to the nature of the intervention, which involves dose modification and clinical monitoring based on the Treatment-Related Toxicity Risk Model (TRTRM/ ACTTOP). Outcome assessors responsible for determining study endpoints, including treatment-related toxicities, emergency visits, hospitalizations, and mortality, are blinded to treatment allocation. Outcome data are obtained through independent review of electronic medical records and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 without access to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 20, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)