drugset / Trial / NCT00515190

Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

NCT00515190

Phase 2 Unknown 198 enrolled National Cancer Center, Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.

Timeline

Start
2007-07
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxaliplatin Small molecule 130 mg/m2 Intravenous
Comparator S-1 Small molecule 80 mg/m2 Oral

Indications