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NCT Number: NCT07517211

A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, FAST-GO Study

This study evaluates how the treatment for gastroesophageal cancer affects physical function in patients who receive chemotherapy as part of their treatment for gastroesophageal cancer.

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Key information

About this study

PRIMARY OBJECTIVE:

I. To determine the change in physical function from baseline to 6 months of treatment, as measured by the short physical performance battery (SPPB).

OUTLINE: This is an observational study.

Patients undergo blood sample collection as well as complete surveys, physical function tests and may complete an interview on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * Adults ≥ 18 years old at the start of study treatment.
  • New diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma.
  • Plan to start systemic therapy for resectable or potentially resectable disease.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • * Patients with stage I disease with plans to undergo endoscopic resection or surgery alone without perioperative systemic therapy.
  • Metastatic disease at the time of diagnosis.
  • Patients who are unable to provide informed consent.
  • Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
  • Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, increase muscle strength, or improve cognitive function.

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Change in SPPB

    Time frame: Through the end of cancer treatment, an average of 6 months

    Will characterize the levels of function at each time point and longitudinal changes in function using descriptive statistics (means, SDs, change scores) in the overall patient sample and by pre-treatment/treatment variables. To assess the associations between pre-treatment/treatment variables and change in function, we will use linear regression models with SPPB change score from baseline to 6 months as the dependent variable and pre-treatment demographic, clinical, and geriatric assessment characteristics as the predictor variables, controlling for the patient's pre-treatment level of function. Potential predictors will be examined individually and in a parsimonious multivariable model. We will also fit linear mixed models for each outcome variable using measurements at all time points and examine differences in change over time by pre-treatment/treatment variables using interaction terms. Time will be treated as a categorical variable, using indicator variables of time.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer (FAST-GO)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 8, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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