Prediction and regulation of 5-FU blood concentratio

Phase 1

• Conditions: The clinical trial is conducted in patients undergoing FOLFOX, FOLFIRI and FOLFIRINOX chemotherapy. Most of these patients have colorectal or pancreatic cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003740-77-NL
• Lead Sponsor: Amsterdam UMC location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patient undergoing FOLFOX, FOLFIRI or FOLFIRINOX treatment.
2. Patient with age = 18.
3. Patient is able and willing to give written informed consent.
4. Patient is able and willing to undergo extra blood sampling for 5-FU analysis.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient’s safety.
2. Inability to undergo additional blood sampling.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified