NCT05780684

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	FOX dose-escalation algorithm	Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens

Timeline

• Start date: 2023-07-14
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-03-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States