Actively Recruiting
Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer
Led by Dartmouth-Hitchcock Medical Center · Updated on 2025-09-22
36
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including stomach, esophagus, appendix, small bowel, and ampullary cancers)
- Clinically appropriate staging imaging of chest, abdomen, and pelvis within 30 days before registration
- ECOG Performance Status of 0-1
You will not qualify if you...
- Prior treatment with oxaliplatin or fluoropyrimidine chemotherapy (except radiation-sensitizing fluoropyrimidine chemotherapy)
- Receipt of systemic chemotherapy within 6 months before starting the FOX regimen (except radiation-sensitizing chemotherapy)
- Known mismatch repair deficiency or microsatellite instability-high disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Any confirmed second malignancy likely to need systemic therapy during the 6-month study period
- Baseline lab abnormalities: ANC less than 2,500/mm3, platelet count less than 100,000/mm3, hemoglobin less than 9 g/dL, creatinine above 1.5 times the upper limit of normal, total bilirubin above 1.5 times the upper limit of normal, AST/ALT above 5 times the upper limit of normal
- Inability to provide informed consent
- Pregnancy or breastfeeding
- Being incarcerated, homeless, or having active substance use disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
R
Research Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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