NCT02564367

Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction

Multicenter Phase I/II Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter trial in Germany: Feasibility Study of Adjuvant Treatment with S-1 in Patients after R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction with the aim to show the feasibility and tolerability of adjuvant S-1 treatment in Caucasian patients and to determine the recommended dose for the treatment regimen.

Detailed description

Patients will be enrolled in one cohorts. Cohort 1 consists of 30 patients who receive S-1 twice daily for 18 cycles (D1-14 q 3 wks).

Conditions

• Adenocarcinoma,Stomach
• Adenocarcinoma, Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	S-1	18 cycles S-1, orally administered twice daily D1-14, q 3 wks S-1 starting dose: 2 x 30 mg/m\^2 body surface area (BSA), D1-14, q 3 wks First dose reduction: 2 x 25 mg/m\^2 BSA, D1-14, q 3 wks Second dose reduction: 2 x 20 mg/m\^2 BSA, D1-14, q 3 wks

Timeline

• Start date: 2015-10-06
• Primary completion: 2019-03-01
• Completion: 2020-03-06
• First posted: 2015-09-30
• Last updated: 2021-04-29

Locations

1 site across 1 country: Germany