Esophagogastric Cancer Clinical Trial
Official title:
Personalized Therapy for Esophagogastric Cancer Using Thymidylate Synthase Genetic Markers
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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