Study on Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients with Gastrointestinal Cancers

Sponsor: University of Vermont Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06648785

Provider View

This clinical trial is testing a new schedule for giving the chemotherapy drugs capecitabine and oxaliplatin to see if it causes fewer side effects than the usual treatment plans for patients with gastrointestinal cancers.

Patient Parameters

Program Overview

The purpose of this study is to find out if a modified way of giving the chemotherapy drugs capecitabine and oxaliplatin can reduce side effects compared to the standard treatment plans known as FOLFOX or CAPOX. This study is not randomized, meaning all participants will receive the same treatment, and it focuses on how well patients tolerate the new schedule and what side effects they experience.

Eligibility Criteria

Inclusion Criteria

  • Have a gastrointestinal cancer.
  • Doctor plans to treat with CAPOX or FOLFOX (mFOLFOX6) for more than 3 months, not aiming to cure the cancer.
  • Other cancer medications like bevacizumab or immunotherapy can be used alongside the study treatment.

Exclusion Criteria

  • Do not meet the standard blood cell counts needed for chemotherapy:
    • Neutrophil count of at least 1500.
    • Platelet count of at least 100,000.
  • Do not meet the standard liver function needed for chemotherapy:
    • AST and ALT levels no more than 5 times the normal limit.
    • Total bilirubin no more than 1.5 times the normal limit.
  • Do not meet the standard kidney function needed for chemotherapy:
    • Serum creatinine no more than 1.2 or creatinine clearance at least 30 ml/min.
  • Planning to receive another type of chemotherapy like irinotecan.

Locations

FACILITYZIPCITYSTATE
University of Vermont Medical Center05401BurlingtonVermont
University of Vermont05401BurlingtonVermont

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