Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers (TOX-FRAIL)

Ankara Etlik City Hospital

Status: Active, not recruiting

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

Treatments: Other: Adjuvant Chemotherapy (Standard of Care)

Study type: Observational

Funder types: Other

Identifiers

NCT07184047

AEŞH-BADEK-2024-039 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 72 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 1 patient group

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.

Treatment:

Other: Adjuvant Chemotherapy (Standard of Care)