[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630227":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":54,"collaborators":12,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":12,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":12,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002F ACTTOP).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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\u002F 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.",[18],"Other: TRTRM-guided risk-stratified treatment strategy",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"TRTRM-guided risk-stratified treatment strategy","The Treatment-Related Toxicity Risk Model (TRTRM\u002FACTTOP) 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\u002FACTTOP 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\u002FACTTOP-guided dose modification. Intermediate- and high-risk patients receive weekly monitoring by healthcare professionals during the initial treatment period.",[14],[25],{"name":26,"affiliation":5,"role":27},"Wing-Lok Wendy Chan, MBBS","PRINCIPAL_INVESTIGATOR",[29,34],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","852-22553111","5124","winglok@hku.hk",{"name":35,"role":30,"phone":31,"phoneExt":36,"email":37},"Horace Shek, BSc","4352","oncology@hku.hk",[39],{"facility":40,"status":41,"city":42,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Department of Clinical Oncology, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong SAR","RECRUITING","Hong Kong","HK",{"type":45,"coordinates":46},"Point",[47,48],114.17469,22.27832,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":53,"phoneExt":12,"email":33},"Wing Lok Chan","(852) 2255-3111",{"type":27,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Wing Lok Wendy Chan","Clinical Associate Professor","100630227","trtrm-acttop--guided-dosing-strategy-in-older-patients-with-cancer-100630227",false,"NCT07484932","TRTRM (ACTTOP) -Guided Dosing Strategy in Older Patients With Cancer","Clinical Utility of the Treatment-related Toxicity Risk Model (TRTRM\u002F ACTTOP) in Older Patients With Cancer: a Randomised Controlled Trial","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\u002Fsecond-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","ALL","65 Years",{"count":67,"type":68},400,"ESTIMATED","INTERVENTIONAL",[71],"NA","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.",[74,75],"Cancer (Solid Tumors)","Geriatric Oncology",[77,78,79,80,81],"toxicities","prediction model","ACTTOP","Older patients","geriatrics","2026-05-16",{"date":84,"type":85},"2026-05-20","ACTUAL",{"date":87,"type":85},"2026-05-04",{"date":89,"type":68},"2030-07-31",{"name":5,"class":6},1]