NCT07184047Completed
Longitudinal Geriatric Vulnerability, Chemotherapy Toxicity, and Functional Outcomes in Older Adults With Gastrointestinal Cancer
Beyond Baseline Frailty Screening: Longitudinal Geriatric Vulnerability, Severe Chemotherapy Toxicity, and Functional Decline in Older Adults With Nonmetastatic Gastrointestinal Cancer
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
Older adults with gastrointestinal cancers may be more likely to experience side effects from chemotherapy and difficulties with everyday activities. These problems are not always explained by age alone. Changes in nutrition, physical strength, general health, and independence may also affect how well a person tolerates cancer treatment. The purpose of the VITAL-GI study is to better understand how health-related vulnerability in older adults is associated with chemotherapy side effects and changes in daily functioning over time. This is an observational study involving adults aged 65 years or older with gastrointestinal cancer that has not spread to distant parts of the body. Participants receive chemotherapy as part of their usual medical care, either before or after surgery, according to their treatment plan. The study does not assign chemotherapy treatments or change routine care. Researchers use questionnaires and clinical information to assess general health, nutrition, physical abilities, independence, and the risk of chemotherapy side effects. Assessments are performed when chemotherapy begins and approximately 3 and 6 months later. The study examines whether initial health assessments can help identify people who are more likely to experience serious chemotherapy side effects. It also examines how health, daily activities, symptoms, and quality of life change during treatment. The findings may help researchers better understand the supportive care needs of older adults receiving chemotherapy for gastrointestinal cancer.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 132 (actual)
- First submitted
- 14 Sept 2025
- Start date
- 15 Jan 2024
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Ankara Etlik City Hospital
- Diseases
- Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT07184047
What you commit to
- Study type: Observational
- Participants enrolled: 132
- From 15 Jan 2024 to the primary completion date, 1 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No planned systemic cytotoxic chemotherapy during the study observation period.
- Concurrent participation in an interventional clinical trial that interferes with chemotherapy selection, toxicity assessment, or longitudinal study evaluations.
Other illness
- Evidence of distant metastatic disease (stage IV) at baseline.
- Severe cognitive impairment or another condition preventing valid baseline geriatric and functional assessment when no protocol-approved assessment assistance is available.
Other
- ECOG performance status ≥3 at study enrollment.
- Inability to provide informed consent according to the approved study procedures.
Who the study is looking for
- Age ≥65 years at the time of enrollment.
- Histologically confirmed nonmetastatic or locally advanced gastrointestinal malignancy, including colorectal, pancreatic, gastric, biliary tract, or other protocol-eligible gastrointestinal cancers.
- Clinical stage II or III disease, or locally advanced nonmetastatic disease without a separately specified stage II or III classification.
- Planned initiation of standard-of-care adjuvant or neoadjuvant systemic chemotherapy, including fluoropyrimidine-, oxaliplatin-, irinotecan-, or gemcitabine-based regimens, as clinically appropriate.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at baseline.
- Ability to undergo baseline comprehensive geriatric assessment and participate in scheduled follow-up evaluations at approximately 3 and 6 months after chemotherapy initiation.
- Ability to complete the required geriatric, nutritional, sarcopenia, functional, symptom, and quality-of-life assessments independently or with assistance permitted under the study protocol.
- Provision of written informed consent before study participation.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Etlik City Hospital Medical Oncology Department Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.