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Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers

NCT07184047 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2026-02-20

No results posted yet for this study

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. 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

  • Gastrointestinal Cancers
  • Frailty
  • Sarcopenia in Elderly
  • Malnutrition Elderly
  • Toxicity Due to Chemotherapy
  • Colorectal Cancer
  • Gastric Cancer (GC)
  • Pancreatic Cancer Resectable
  • Biliary Tract Cancer
  • Esophageal Cancer (EsC)
  • Older Adults (65 Years and Older)

Interventions

OTHER

Adjuvant Chemotherapy (Standard of Care)

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.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Principal Investigators

  • Galip Can Uyar, MD · Ankara Etlik City Hospital

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-02-01
Completion
2026-02-19

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07184047 on ClinicalTrials.gov