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| ID | Type | Description | Link |
|---|---|---|---|
| AEÅžH-BADEK-2024-039 | Other Identifier | Ankara Etlik City Hospital Scientific Research Ethics Committee |
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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.
Background
Gastrointestinal (GI) cancers in older adults are often accompanied by frailty, malnutrition, and functional decline, which increase the risk of chemotherapy-related toxicity. While chemotherapy in the adjuvant setting is standard of care, toxicities may impair quality of life and adherence in this vulnerable population. Validated frailty screening tools may improve risk stratification and supportive care strategies.
Study Design
Type: Prospective, observational, single-center, non-randomized study
Site: Ankara Etlik City Hospital, Department of Medical Oncology
Target enrollment: 72 patients
Population: Patients ≥65 years with non-metastatic or locally advanced GI cancers (esophageal, gastric, colorectal, pancreatic, or biliary tract) scheduled for adjuvant chemotherapy only
Exclusion: ECOG PS ≥3, severe frailty at baseline, patients planned for chemoradiotherapy, or those receiving neoadjuvant chemotherapy
Timeline:
First patient in: January 15, 2024
Accrual closure: January 1, 2025
Final data collection (PFS/OS): January 1, 2026
Assessments
Patients will be assessed at baseline, mid-treatment (~3 months), and at the end of chemotherapy (~6 months). All instruments have been validated in Turkish populations:
G8 Screening Tool
Range: 0-17
Cut-off ≤14 = frailty risk
VES-13 (Vulnerable Elders Survey-13)
Range: 0-13
Cut-off ≥3 = frailty
SARC-F (Sarcopenia screening tool)
Range: 0-10
Cut-off ≥4 = probable sarcopenia
Mini Nutritional Assessment - Short Form (MNA-SF)
12-14 = normal nutrition
8-11 = at risk
0-7 = malnutrition
Katz Index of Activities of Daily Living (ADL)
Range: 0-6 (higher = more independence)
Lawton-Brody Instrumental Activities of Daily Living (IADL)
Range: 0-8 (higher = more independence)
ECOG Performance Status
Range: 0-5 (higher = worse functional state)
Outcomes
Primary outcome:
Predictive value of G8 and VES-13 for grade ≥2 chemotherapy-related toxicity (CTCAE v5.0)
Secondary outcomes:
Associations between frailty and sarcopenia, nutrition, functional independence, and ECOG
One-year Progression-Free Survival (PFS)
One-year Overall Survival (OS)
Statistical Analysis
Categorical variables will be analyzed using Chi-square or Fisher's exact test. Continuous variables will be compared using t-test or Mann-Whitney U test, depending on distribution. Survival analyses (PFS, OS) will be estimated with Kaplan-Meier method. A p-value <0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Chemotherapy Cohort | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Chemotherapy (Standard of Care) | Other | Patients aged 65 years and older with non-metastatic or locally advanced gastrointestinal cancers will receive standard adjuvant chemotherapy regimens as part of routine clinical practice. Regimens may include FOLFOX, CAPEOX, FOLFIRI, FOLFOXIRI, FOLFIRINOX, capecitabine, gemcitabine, 5-FU/leucovorin, or oxaliplatin-based combinations, depending on tumor type and physician decision. No investigational drugs or experimental interventions are administered. The study is observational, and all treatments follow standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive Value of the Geriatric-8 (G8) and the Vulnerable Elders Survey-13 (VES-13) Frailty Scales for Chemotherapy-Related Toxicity | 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. | Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Frailty Scores with the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) Questionnaire | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with sarcopenia risk assessed by the Strength, Assistance with walking, Rise from a chair, climb stairs, and Falls (SARC-F) questionnaire (range 0-10; cut-off ≥4; validated in Turkish). Scores will be reported as points on the scale. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of at least 72 older patients (≥65 years) with non-metastatic or locally advanced gastrointestinal cancers who are scheduled to receive standard adjuvant chemotherapy at Ankara Etlik City Hospital, Department of Medical Oncology. Patients will be assessed for frailty, sarcopenia, nutritional status, functional independence, and performance status at baseline, 3 months, and 6 months during chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Galip Can Uyar, MD | Ankara Etlik City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik City Hospital, Medical Oncology Department | Ankara | Yenimahalle | 06210 | Turkey (Türkiye) |
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| Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy) |
| Correlation of Frailty Scores with the Mini Nutritional Assessment - Short Form (MNA-SF) Questionnaire | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with nutritional risk assessed by the Mini Nutritional Assessment - Short Form (MNA-SF) questionnaire (range 0-14; categories: 12-14 = normal, 8-11 = risk, 0-7 = malnutrition; validated in Turkish). Scores will be reported as points on the scale. | Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy) |
| Correlation of Frailty Scores with the Katz Index of Activities of Daily Living (ADL) | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with functional independence assessed by the Katz Index of Activities of Daily Living (ADL; range 0-6; validated in Turkish). Scores will be reported as points on the scale. | Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy) |
| Correlation of Frailty Scores with the Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with functional independence assessed by the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale (range 0-8; validated in Turkish). Scores will be reported as points on the scale. | Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy) |
| Correlation of Frailty Scores with the Eastern Cooperative Oncology Group (ECOG) Performance Status | Correlation of Geriatric-8 and Vulnerable Elders Survey-13 frailty scores with the Eastern Cooperative Oncology Group (ECOG) Performance Status (range 0-5; validated in Turkish). Scores will be reported as points on the scale. | Baseline, 3 months after chemotherapy initiation, and 6 months (end of adjuvant chemotherapy). |
| Overall Survival (OS) | Overall survival will be defined as the time from chemotherapy initiation to death from any cause, measured in months. | 12 months after chemotherapy initiation |
| Progression-Free Survival (PFS) | Progression-free survival will be defined as the time from chemotherapy initiation to disease progression or death from any cause, measured in months. | 12 months after chemotherapy initiation. |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D000073496 | Frailty |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004938 | Esophageal Neoplasms |
| D055948 | Sarcopenia |
| D044342 | Malnutrition |
| D058088 | Sarcoglycanopathies |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D001660 | Biliary Tract Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D049288 | Muscular Dystrophies, Limb-Girdle |
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D009468 | Neuromuscular Diseases |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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