drugset / Trial / NCT00816543

Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

NCT00816543 ↗

Phase 2 Completed 41 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of this trial is: * To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved. The secondary objective of this trial are to describe: * The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection. * The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.

Timeline

Start
2008-12
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous
Subject S-1 Small molecule 40 mg/m2 Oral

Indications