Gastrointestinal Cancer (MSK 22-164)

Using a 3-arm RCT, a total of 216 patients will be stratified by age (<50 years versus >50 years) and tumor site (colorectal vs. esophago/gastric) and randomly allocated (1:1:1 ratio) to receive: (i) 90 mins/week, (ii) 150 mins/week, or (iii) 300 mins/week of structured treadmill walking throughout treatment. 30-day post-operative complications will
be evaluated during follow-up.

Treatment Plan: Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered throughout treatment.

Primary objective: To determine the dose-response of aerobic training on chemotherapy tolerability, defined as the proportion of patients receiving chemotherapy who achieve a relative dose intensity for chemotherapy (RDI; ratio of delivered to planned treatment) of >90%.

Secondary objective (1 of 9): To compare chemotherapy RDI (on a continuous scale, %) between AT dose cohorts

Exploratory objective (1 of 9): To explore AT dose-response on tumor response as evaluated by pathologic complete response (pCR) rate, clinical complete response (cCR) rate, and disease-free survival (DFS) rates

Criteria:
Main Inclusion Criteria:

  1. Diagnosed with locally advanced colorectal or esophago/gastric solid tumors as
    defined by one of the following:
    1. Histological confirmation
    2. As per standard of care imaging
  2. Scheduled to receive neoadjuvant chemotherapy
  3. Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
  4. Cleared for exercise participation as per screening clearance via the Physical Activity
    Readiness Questionnaire (PAR-Q+) (Appendix K)

Main Exclusion Criteria:

  1. Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
  2. Receiving treatment for any other diagnosis of invasive cancer
  3. Distant metastatic malignancy of any kind
  4. Mental impairment leading to inability to cooperate

Sponsor: MSK

Location: Hartford Hospital

Contacts: Devon Latney (860-637-5031, Devon.Latney@hhchealth.org) & Hayley Dunnack (860-972-5518, Hayley.Dunnack@hhchealth.org)

MSK_ClinicalTrials_Ad