Status:
NOT_YET_RECRUITING
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Inova Health Care Services
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.
Detailed Description
5-fluorouracil (5-FU) has been the most widely used agent in the treatment of early stage and advanced colorectal cancer. Traditionally, 5-FU dosing is based on body surface area (BSA). However, BSA-d...
Eligibility Criteria
Inclusion
- Males or females at least 18 years of age.
- Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU.
- No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease.
- Adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2.
- Life expectancy \> 3 months.
Exclusion
- Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms have resolved off of steroids.
- At least 4 weeks from any prior surgery or 2 weeks from radiation treatments.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06501989
Start Date
December 15 2025
End Date
August 15 2026
Last Update
April 17 2025
Active Locations (1)
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1
Inova Health Care Service
Falls Church, Virginia, United States, 22042