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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage I Esophageal Adenocarcinoma AJCC v8; Clinical Stage I Esophageal Squamous Cell Carcinoma 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 II Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center
      • Contact: Jingran Ji; Phone Number: 310-825-3181; Email: jingranji@mednet.ucla
      • Principal Investigator: Jingran Ji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non-interventional study; Other Names: Non-Interventional Observational Study; Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jingran Ji, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-1284; NCI-2026-00124 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R03AG095803 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No