Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients

Completed

Conditions studied: Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, 5-FU Containing Therapy Regimens

In brief

The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to characterize the variability of 5-FU levels among CRC patients managed with 5-FU exposure optimization testing and the impact of such management on 5-FU plasma levels and drug doses during the course of chemotherapy.

Key facts

Study ID

NCT02055560

Run by

Saladax Biomedical, Inc.

People needed

146

Starts

2014-01-01

Expected to finish

2015-12-18

Last updated by the study team

2022-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients 18 years of age or older.
• Patients with histologically confirmed colorectal cancer who were treated with an infusional 5-FU regimen between May 1, 2009 and December 31, 2013.
• PK-Guided Cohort: Patients monitored with 5-FU PK-testing at a minimum of two administrations of 5-FU throughout the course of a single infusional 5-FU containing treatment regimen.
• BSA Cohort: Patients who received infusional 5-FU doses calculated based on their BSA.

You may not qualify if…

• Patients less than 18 years of age.
• Patients with concurrent treatment of other active malignancies.
• Patients that underwent radiation therapy concurrently with chemotherapy.

Where it is running

• University of California San Diego — La Jolla, California, United States
• Hematology/Oncology of the North Shore — Skokie, Illinois, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Tennessee Plateau Oncology — Crossville, Tennessee, United States
• Texas Health Physicians Group — Plano, Texas, United States

Full record on ClinicalTrials.gov

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