{"type":"trials","record":{"id":35430,"source_id":"clinicaltrials-gov","external_id":"NCT06055387","title":"Frailty Assessment and Intervention in Elderly Patients with Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy","brief_summary":"Gastric cancer ranks among the top ten leading causes of death in Taiwan. Radical surgery is the sole curative method for gastric cancer. However, our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications. Even after gastric cancer resection, only 70% of patients receive adjuvant chemotherapy, with a particularly low likelihood among those aged ≥ 65 to undergo such treatment. With the increasing elderly population in our country, an increasing number of elderly gastric cancer patients must decide whether they can withstand radical surgery for gastric cancer and whether to undergo adjuvant chemotherapy. Therefore, increasing the rates of elderly gastric cancer patients undergoing radical surgery and adjuvant chemotherapy, as well as improving the success rate of chemotherapy, has become a critical issue. Frailty has been a frequent topic in geriatric medicine in recent years. It involves assessing multifaceted aspects of physical functioning to determine an individual's frailty status, which can help predict the likelihood of severe side effects from medical interventions. International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty. However, there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population. This study is a prospective, open-label, randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgery/chemotherapy in patients diagnosed with gastric cancer. As part of the study protocol, all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment, followed by tailored geriatric interventions. The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications, chemotherapy tolerance, treatment-related toxicity, and overall quality of life among two distinct groups: frail and non-frail patients. Our research team aims to promote widespread frailty assessment and interventions with the following objectives: 1. Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery. 2. Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer. These efforts ultimately aim to improve the survival prognosis of this patient group.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Chang Gung Memorial Hospital","enrollment":300,"countries":["Taiwan"],"start_date":"2022-01-01","completion_date":"2025-12-31","last_update_date":"2025-02-13","source_url":"https://clinicaltrials.gov/study/NCT06055387","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":"Non-frail group","organization":"Chang Gung Memorial Hospital","interventions":["Frailty intervention measures"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system. — After c…","Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-…","Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed…","To compare overall survival between two distinct groups: frail and non-frail patients. — up to 1 year."],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · NONE","source_has_results":false},"controlled_terms":["Gastric Cancer","Frailty intervention measures"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct06055387","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-01-01 to 2025-12-31","comparator":"Non-frail group","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.524Z","intervention":["Frailty intervention measures"],"participants":300,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system. — After c…","Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-…","Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed…","To compare overall survival between two distinct groups: frail and non-frail patients. — up to 1 year."],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/35430","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}