drugset / Trial / NCT02128243
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
Phase 2
Completed
242 enrolled
AIO-Studien-gGmbH
Nordic Pharma SAS · collabTaiho Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim is to assess the relative efficacy of S-1 de-escalation therapy vs. continuation of chemotherapy after induction therapy in patients with metastatic esophagogastric cancer in terms of overall survival.
Timeline
- Start
- 2014-09
- Primary completion
- 2020-10-08
- Completion
- 2020-10-08
Outcome
Met primary endpoint
paper CONCLUSIONS: S-1 maintenance following platinum-based induction therapy leads to non-inferior survival outcomes compared with the continuation of platinum-based combination. PMID 37270871 ↗
Publications
- Stocker G, Lorenzen S, Ettrich T, Herz AL, Longo F, Kiani A, Venerito M, Trojan J, Mahlberg R, Moosmann N, Chibaudel B, Kubicka S, Greil R, Daum S, Geissler M, Larcher-Senn J, Keller G, Lordick F, Haag GM. S-1 maintenance therapy in Caucasian patients with metastatic esophagogastric adenocarcinoma-final results of the randomized AIO MATEO phase II trial. ESMO Open. 2023 Jun;8(3):101572. doi: 10.1016/j.esmoop.2023.101572. Epub 2023 Jun 2.
- Haag GM, Stocker G, Quidde J, Jaeger D, Lordick F. Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer - the multinational MATEO study. BMC Cancer. 2017 Jul 31;17(1):509. doi: 10.1186/s12885-017-3497-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 625 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 50 mg/m2 | — |
| Subject | Epirubicin | Small molecule | 50 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 200 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | — |
| Subject | S-1 | Small molecule | 25 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 30 mg/m2 | Oral |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 800 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 1000 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 2600 mg/m2 | — |