Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer
Recruiting · NCT05780684 · Interventional (participants receive a specific treatment) · Lead sponsor: Dartmouth-Hitchcock Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
FOX dose-escalation algorithm
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States