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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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).\n\nOutcome 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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nRandomization 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.\n\nIn 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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade 3 or Higher Treatment-Related Toxicities', 'timeFrame': '2 months after treatment initiation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Emergency Department Visits Due to Treatment-Related Toxicities', 'timeFrame': '2 months after treatment initiation', 'description': 'Number of participants who experience one or more unplanned emergency department visits attributed to treatment-related toxicities, determined through review of clinical records.'}, {'measure': 'Number of Participants with Unplanned Hospitalizations Due to Treatment-Related Toxicities', 'timeFrame': '2 months after treatment initiation', 'description': 'Number of participants who experience one or more unplanned hospitalizations attributable to treatment-related toxicities, identified through review of electronic medical records.'}, {'measure': 'Number of Participants with Premature Termination of Systemic Anti-Cancer Treatment Due to Treatment-Related Toxicities', 'timeFrame': 'Within 2 months of treatment initiation', 'description': '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.'}, {'measure': 'Early Mortality', 'timeFrame': 'Within 3 months of treatment initiation', 'description': 'Death occurring within three months of starting systemic anti-cancer treatment.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline to 2 months after treatment initiation', 'description': '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.'}, {'measure': 'Overall Survival', 'timeFrame': 'Baseline to 2 years', 'description': 'Time from treatment initiation to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['toxicities', 'prediction model', 'ACTTOP', 'Older patients', 'geriatrics'], 'conditions': ['Cancer (Solid Tumors)', 'Geriatric Oncology']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.hkuctr.com/Study/Show/cd41c1f87d384b83a681bb0ccdb3c74e', 'label': 'Additional study information is available at the HKU Clinical Trials Registry'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.', 'detailedDescription': '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.\n\nParticipants 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).\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 65 or above\n2. A diagnosis of lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, and uterine cancer with histological confirmation or radiological diagnosis\\*\\*\n3. 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.\n4. ECOG performance status of 0-2\n5. Agreement for treatment according to the TRTRM (ACTTOP) -risk strategy if in the TRTRM (ACTTOP) -informed care group\n6. Fluent in English or Chinese\n7. 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.\n\nExclusion Criteria:\n\n1. Planned for radiotherapy alone\n2. Planned for systemic treatment concomitant with radiotherapy\n3. Scheduled to have hormonal therapy alone e.g. tamoxifen, aromatase inhibitors, luteinizing hormone-releasing hormone agonist (LHRHa)\n4. Planned for surgery within 3 months\n5. Dementia or patient mentally not fit for consent'}, 'identificationModule': {'nctId': 'NCT07484932', 'briefTitle': 'TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM/ ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CIRB-2025-629-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': '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).'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group (TRTRM-informed care)', 'description': '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.\n\nTreatment 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.\n\nIntermediate- and high-risk patients receive weekly monitoring by healthcare professionals via telephone or a remote monitoring system.', 'interventionNames': ['Other: TRTRM-guided risk-stratified treatment strategy']}], 'interventions': [{'name': 'TRTRM-guided risk-stratified treatment strategy', 'type': 'OTHER', 'description': '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.\n\nThe 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.\n\nPatients 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.', 'armGroupLabels': ['Intervention group (TRTRM-informed care)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Wing Lok Chan', 'role': 'CONTACT', 'email': 'winglok@hku.hk', 'phone': '(852) 2255-3111'}], 'facility': 'Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Wing-Lok Wendy Chan, MBBS', 'role': 'CONTACT', 'email': 'winglok@hku.hk', 'phone': '852-22553111', 'phoneExt': '5124'}, {'name': 'Horace Shek, BSc', 'role': 'CONTACT', 'email': 'oncology@hku.hk', 'phone': '852-22553111', 'phoneExt': '4352'}], 'overallOfficials': [{'name': 'Wing-Lok Wendy Chan, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Wing Lok Wendy Chan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}