Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients (5-FU RECORD)
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|ClinicalTrials.gov Identifier: NCT02055560|
Recruitment Status : Unknown
Verified December 2015 by Saladax Biomedical, Inc..
Recruitment status was: Enrolling by invitation
First Posted : February 5, 2014
Last Update Posted : November 2, 2016
|Condition or disease|
|Metastatic Colorectal Cancer Adjuvant Colorectal Cancer 5-FU Containing Therapy Regimens|
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Retrospective Data Comparison of Toxicity and Efficacy in Colorectal Cancer (CRC) Patients Managed With and Without 5-FU Exposure Optimization Testing|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
CRC patients who were treated with 5-FU containing therapy regimen where 5-FU dosing was monitored and optimized using PK-guided dose adjustment.
CRC patients who were treated with 5-FU containing therapy regimen where 5-FU dosing was done according to body surface area (BSA) and no PK monitoring was performed.
- Variability of 5-FU plasma levels (exposure) [ Time Frame: At each cycle after initiation of 5-FU containing therapy, or approximately every 1 - 2 weeks, depending on the 5-FU infusion schedule, for up to ~12 cycles (~24 weeks) total. ]At each treatment cycle (i.e. Cycle 1, Cycle 2, Cycle 3, etc.), we will plot the 5-FU exposure (i.e. AUC value) and determine the average, median, standard deviation, and percent coefficient of variation (%CV). These statistics will also be determined for all 5-FU exposure values combined.
- Hematological and non-hematological toxicity rates [ Time Frame: From initiation of the 5-FU containing therapy until up to 30 days after its discontinuation, or for up to ~28 weeks total ]Incidence of 5-FU related toxicities, such as diarrhea, oral mucositis, neutropenia, anemia, febrile neutropenia, thrombocytopenia, nausea, etc., will be recorded throughout the duration of the 5-FU containing therapy regimen.
- Tumor response [ Time Frame: At each follow-up disease assessment following initiation of 5-FU containing thearpy, expected to occur an average of every 8 - 12 weeks, until discontinuation of therapy, or up to ~24 weeks total. ]Tumor response rates as determined by imaging [classified as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)].
- Progression-free survival (PFS) [ Time Frame: up to 3.5 years after initiation of 5-FU containing therapy regimen ]
- Overall survival [ Time Frame: up to 3.5 years after initiation of 5-FU containing therapy regimen ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055560
|United States, California|
|University of California San Diego|
|La Jolla, California, United States, 92093|
|United States, Illinois|
|Hematology/Oncology of the North Shore|
|Skokie, Illinois, United States, 60076|
|United States, Nevada|
|Comprehensive Cancer Centers of Nevada|
|Las Vegas, Nevada, United States, 89169|
|United States, Tennessee|
|Tennessee Plateau Oncology|
|Crossville, Tennessee, United States, 38555|
|United States, Texas|
|Texas Health Physicians Group|
|Plano, Texas, United States, 75093|
|Study Director:||Craig Miller, B.S.||Saladax Biomedical, Inc.|