Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines

NACompletedINTERVENTIONAL
Enrollment

1,103

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

January 31, 2018

Study Completion Date

March 31, 2018

Conditions
Neoplasms
Interventions
DRUG

Fluoropyrimidine (capecitabine or 5-fluorouracil)

Patient that are a heterozygous carrier of a DPYD variant will receive a reduced dosage of capecitabine or 5-fluorouracil (25-50% reduction, depending on which SNP is identified). The dose will be titrated in subsequent cycles, to achieve maximal safe exposure. Patients that are wild type (not carrying any of the for DPYD variants) will receive a normal (full) dose.

Trial Locations (17)

Unknown

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam

Wilhelmina Hospital Assen, Assen

Amphia Hospital, Breda

Reinier de Graaf Hospital, Delft

Deventer Hospital, Deventer

Hospital Gelderse Vallei, Ede

Catharina Hospital, Eindhoven

Leiden University Medical Center, Leiden

Maastricht University Medical Center, Maastricht

Canisius-Wilhelmina Hospital, Nijmegen

Laurentius Hospital, Roermond

Bravis Hospital, Roosendaal

Erasmus MC, Rotterdam

Franciscus Gasthuis & Vlietland, Rotterdam

Haga Hospital, The Hague

Medical Center Haaglanden, The Hague

University Medical Center Utrecht, Utrecht

All Listed Sponsors
lead

The Netherlands Cancer Institute

OTHER

NCT02324452 - Safety, Feasibility and Cost-effectiveness of Genotype-directed Individualized Dosing of Fluoropyrimidines | Biotech Hunter | Biotech Hunter