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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* 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.

Disqualifiers

* 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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Non-Interventional Study
Other intervention
Non-interventional study

Treatment groups

72 Participants

are divided into 1 treatment group

Group A: Observational1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Sponsors and contacts

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Jonsson Comprehensive Cancer Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: