Recruiting

5-FU

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT05780684

Conditions

Colorectal Cancer

Esophagus Cancer

Appendix Cancer

Small Bowel Cancer

Ampullary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FOX dose-escalation algorithm

Study Details

Brief 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.

Conditions

Colorectal Cancer

Esophagus Cancer

Appendix Cancer

Small Bowel Cancer

Ampullary Cancer

Study ID

NCT05780684

Start date

Jul 14, 2023

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Arm

All patients in this single-study arm will be exposed to the FOX regimen, an adaptively dose-escalated chemotherapy regimen. The FOX regimen is comprised of oxaliplatin 85 mg/m2 IV on Day 1; leucovorin calcium 350 mg IV on Day 1; and infusional 5-FU IV over 46 hours (Days 1 and 2) - starting at a dose of 2,400 mg/m2 and adaptively adjusted toward a maximum dose of 3,200 mg/m2 over Cycles 2-4 using a clinical algorithm.

Interventions

FOX dose-escalation algorithm

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

Primary outcome measure

  • Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen [ Time Frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days) ]

Central Contacts and Locations

Central contacts

Research Nurse

603-653-3637cancer.research.nurse@hitchcock.org

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Gabriel A Brooks, MD

603-650-9474gabriel.a.brooks@hitchcock.org

Principal Investigator:

Gabriel A Brooks, MD

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jun 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-06-22.