Clinical trial · Observational
Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers
Effectiveness of G8 and VES-13 Frailty Scales in Predicting Chemotherapy Toxicity in Older Patients With Gastrointestinal Cancers: A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the effectiveness of the G8 and VES-13 frailty scales in predicting chemotherapy-related toxicity in older patients with gastrointestinal cancers receiving adjuvant chemotherapy. Older adults are more vulnerable to treatment-related side effects due to age-related declines in physiological reserve. Early identification of frailty may help individualize treatment decisions and optimize supportive care. This is a prospective, single-center, observational study conducted at Ankara Etlik City Hospital. A total of 72 patients aged 65 years and older with non-metastatic or locally advanced gastrointestinal cancers scheduled for adjuvant chemotherapy will be included. Frailty, sarcopenia, nutritional status, functional independence, and performance status will be assessed at baseline, 3 months, and at the end of chemotherapy. The primary aim is to determine the predictive value of G8 and VES-13 scores for chemotherapy-related toxicity. Secondary aims include exploring the associations between frailty, nutritional status, sarcopenia, daily living activities, and treatment tolerance. Additionally, one-year progression-free survival (PFS) and overall survival (OS) will be analyzed.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer (EsC) | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.85 |
| Frailty | — | UNRESOLVED | — |
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancers | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Malnutrition Elderly | — | UNRESOLVED | — |
| Older Adults (65 Years and Older) | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Chemotherapy (Standard of Care) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adjuvant Chemotherapy Cohort
- description
- Older patients (≥65 years) with non-metastatic or locally advanced gastrointestinal cancers receiving standard adjuvant chemotherapy (e.g., FOLFOX, CAPEOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, capecitabine, gemcitabine, 5-FU/leucovorin, or oxaliplatin-based regimens). Patients will undergo frailty, nutritional, sarcopenia, functional, and performance status assessments at baseline, 3 months, and at the end of chemotherapy. Treatment will follow routine clinical practice, and no investigational intervention will be administered.
- interventionNames
- Other: Adjuvant Chemotherapy (Standard of Care)
Primary outcomes (1)
- measure
- Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity
- timeFrame
- Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy)
- description
- The predictive ability of the G8 (score 0-17; cut-off ≤14) and VES-13 (score 0-13; cut-off ≥3) frailty screening tools in identifying older patients (≥65 years) with gastrointestinal cancers who are at risk of developing grade ≥2 chemotherapy-related toxicity. Toxicities will be assessed according to CTCAE version 5.0 and reported as the proportion (%) of patients with grade ≥2 events. Both frailty tools have validated Turkish versions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥65 years * Histologically confirmed non-metastatic or locally advanced gastrointestinal cancers (esophageal, gastric, colorectal, pancreatic, biliary tract) * Planned to receive adjuvant chemotherapy (standard regimens such as FOLFOX, CAPEOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, capecitabine, gemcitabine, 5-FU/leucovorin, or oxaliplatin-based regimens) * ECOG Performance Status 0-2 * Ability to complete frailty and functional assessment questionnaires (G8, VES-13, SARC-F, MNA-SF, Katz ADL, Lawton-Brody IADL) * Signed informed consent Exclusion Criteria: * ECOG Performance Status ≥3 * Patients planned for neoadjuvant chemotherapy or chemoradiotherapy * Prior systemic chemotherapy or radiotherapy for the same cancer diagnosis * Severe cognitive impairment preventing questionnaire completion * Patients with advanced frailty at baseline screening * Concurrent enrollment in another interventional clinical trial
References
Publications (0)
Data not yet available