S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells. PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.
Timeline
- Start
- 2012-02
- Primary completion
- 2018-03
- Completion
- 2019-09-19
Outcome
Mixed primary results
registry MEDIAN Arm I: 5.9 (4.1 to 7.1) months NCT01498289 ↗
registry MEDIAN Arm II: 2.8 (1.7 to 4.1) months NCT01498289 ↗
registry analysis (superiority test); Arm I vs Arm II; p = 0.02 NCT01498289 ↗
registry analysis (superiority test); Arm I FOLFOX vs Arm II IT; p = 0.83 NCT01498289 ↗
registry analysis (superiority test); Arm I vs Arm II; p = 0.20 NCT01498289 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 65 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |