NCT05780684Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 10 Mar 2023
- Start date
- 14 Jul 2023
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- NCT number
- NCT05780684
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 14 Jul 2023 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Known mismatch repair deficiency or microsatellite instability-high disease
- 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
Lab values
- 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
Other
- Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.