Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.

Trial Details

NCT ID
NCT05780684
Phase
NA
Sponsor
Dartmouth-Hitchcock Medical Center
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • FOX dose-escalation algorithm
Locations (sample)
  • Lebanon, New Hampshire, United States|43.64229,-72.25176

Key Eligibility Criteria

  • Age ≥ 18 years
  • Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomac…
  • Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
  • ECOG Performance Status: 0-1

For full eligibility, visit ClinicalTrials.gov.

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