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

NCT07517211 | Not Yet Recruiting

• 3 other identifiers: 25-1284NCI-2026-00124R03AG095803
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clinical Stage I Esophageal Adenocarcinoma AJCC v8; Clinical Stage I Gastric Cancer AJCC v8; Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage II Gastric Cancer AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Change in SPPB

  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.

  Through the end of cancer treatment, an average of 6 months

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early stage esophageal, gastroesophageal junction, or gastric cancer who plan to start systemic therapy.

You may qualify if:

• \* 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.

You may not qualify if:

• \* 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Study Officials

• Jingran Ji

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

US (1)