Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers
Status:
Withdrawn
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
In this study the investigators aim to: 1) confirm the objective response rate (ORR) observed
in the investigators initial study for patients with the TSER*2/*2 genotype 2) determine
whether PEMOX regimen is more worthy of future development for this patient genotype selected
population than FOLFOX based on the data indicating that pemetrexed may be a better TS
targeted agent than 5-FU.
Patients who are homozygous for the TSER*2 allele (TSER*2/*2) will be able to continue in the
study and will be randomized. Patients with other TSER genotypes will not be included and
will be considered screen fails.
The first 8 patients with the TSER*2/*2 genotype will be randomized 1:1 to receive treatment
with either PEMOX or FOLFOX (4 in each group).
Analysis of the objective response rate (ORR) in each treatment arm will occur after the
first 8 patients are enrolled. Using the proposed Bayesian design, subsequent patients will
be preferentially assigned to the "better performing" treatment arm based on continuous
real-time reassessments of ORR results.