Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 2, 2026
Date Accepted: Sep 25, 2026
Geriatric Assessment–Based Stratification to Evaluate Treatment Intensity, Quality of Life, and Survival in Older Patients with Metastatic Colorectal Cancer: Protocol for a Prospective Observational Study
ABSTRACT
Background:
Older patients with metastatic colorectal cancer (mCRC) are a heterogeneous population with wide variability in functional status, frailty, cognition, nutritional reserve, and comorbidity burden. Treatment decisions are often guided primarily by chronological age and performance status, which may not adequately capture vulnerability or patient-centered outcomes in this population.
Objective:
This study aims to prospectively evaluate associations of baseline geriatric assessment (GA)-derived frailty and functional status with initial treatment intensity, overall survival (OS), and quality of life (QOL) in older patients with mCRC receiving first-line systemic therapy in routine clinical practice.
Methods:
Baseline GA includes activities of daily living, instrumental activities of daily living, Clinical Frailty Scale, Mini-Cog, nutritional assessment, Charlson Comorbidity Index (excluding cancer-related items), and ECOG performance status. Blood-based prognostic biomarkers, including the Prognostic Nutritional Index and Neutrophil-to-Lymphocyte Ratio, are also collected. Initial treatment intensity is defined according to the first-line systemic regimen selected at baseline, whereas subsequent local therapies are recorded separately. QOL is assessed using the EORTC QLQ-C30 at baseline and at 8-12 weeks after treatment initiation.
Results:
Ethical approval has been obtained from the Ethics Committee of Kawasaki Medical School (approval No. 7048-00), and the study is registered in the UMIN Clinical Trials Registry (UMIN000060489). Study initiation is scheduled following the completion of all necessary administrative and licensing approvals. Participant recruitment and baseline assessments will commence at study initiation, with early QOL follow-up planned at 8-12 weeks. Recruitment is planned for approximately 2.5 years with an anticipated sample size of about 100 participants.
Conclusions:
This protocol describes a pragmatic GA-based observational framework to examine associations between pre-treatment vulnerability, initial treatment intensity, survival outcomes, and patient-reported QOL in older patients with mCRC. The study is expected to generate clinically relevant hypotheses for individualized, patient-centered treatment strategies and future geriatric oncology research. Clinical Trial: the UMIN Clinical Trials Registry (UMIN000060489)
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.