RecruitingNot ApplicableNCT05780684

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen


Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

36 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adjusting the dose of 5-FU (fluorouracil) — a chemotherapy drug — based on blood level monitoring can improve outcomes for people with gastrointestinal cancers. Standard chemotherapy doses are based on body size, but individual metabolism varies. The goal is to personalize dosing to maximize effectiveness and reduce side effects. **You may be eligible if:** - You are 18 years old or older - You have metastatic or locally advanced colorectal cancer, or another gastrointestinal cancer (stomach, esophagus, small bowel, appendix, or ampullary cancers) that cannot be surgically removed - You have had appropriate imaging of the chest, abdomen, and pelvis within the past 30 days - Your general health is good (ECOG performance status 0–1) **You may NOT be eligible if:** - You have previously received oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing doses) - You have received systemic chemotherapy in the past 6 months for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFOX dose-escalation algorithm

Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens


Locations(1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

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NCT05780684


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