Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

This study is looking at a new way to give chemotherapy for certain gastrointestinal cancers, including colorectal, esophageal, appendix, small bowel, and ampullary cancers. It's testing an individualized approach to increase the dose of 5-FU (a chemotherapy drug) for patients who tolerate the initial dose well. You would also receive oxaliplatin chemotherapy at standard doses. The main goal is to see if this dose-escalation method is practical and effective. We are looking for about 36 participants aged 18 or older with metastatic or locally advanced/inoperable cancer. The study is currently unclear on its recruitment status.

Study design: This is a single-arm study, meaning all participants receive the same treatment, and plans to enroll 36 patients. It is an interventional study, but the phase is not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint is measured through day 1 of Cycle 6 of the FOX regimen, with each cycle lasting 14 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Recruiting

NAAges 18+InterventionalTreatment

Dartmouth-Hitchcock Medical Center

~36 participants

Updated 2026-06-22 on ClinicalTrials.gov

What's tested:FOX dose-escalation algorithm

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen

Measured over Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)

Conditions

Colorectal Cancer

Esophagus Cancer

Appendix Cancer

Small Bowel Cancer

Ampullary Cancer

Where it's being run

1 sites across 1 states

New Hampshire1

Study leadership

Gabriel A Brooks, M.D. · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Research Nurse

[email protected]

603-653-3637

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years

Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)

Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration

ECOG Performance Status: 0-1

Exclusion

Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)

Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)

Known mismatch repair deficiency or microsatellite instability-high disease

Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening

Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator

Any of the following baseline laboratory abnormalities:

Absolute neutrophil count (ANC) \< 2,500/mm3

Platelet count \< 100,000/mm3

Hemoglobin \< 9 g/dL

Creatinine \> 1.5 x ULN

Total bilirubin \> 1.5 x ULN

AST/ALT \> 5 x ULN

Patients who are unable to provide informed consent

Patients who are pregnant or breastfeeding

Patients who are incarcerated, homeless, or have active substance use disorders

What this trial measures

Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimenThrough day 1 of Cycle 6 of FOX regimen (cycle length is 14 days)
The proportion of patients who receive dose-intensified infusional 5-FU (dosed at greater than or equal to 2,800 mg/m2) in Cycle 6 of the FOX regimen.

Trialytics