drugset / Trial / NCT00515190
Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Comparator | S-1 | Small molecule | 80 mg/m2 | Oral |