Status:
ACTIVE_NOT_RECRUITING
Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers
Lead Sponsor:
Ankara Etlik City Hospital
Conditions:
Gastrointestinal Cancers
Frailty
Eligibility:
All Genders
65+ years
Brief Summary
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. ...
Detailed Description
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 chemot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07184047
Start Date
January 15 2024
End Date
January 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06210