Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-04 @ 1:19 PM
Study NCT ID:
NCT02564367
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Adjuvant Treatment With S-1 in Patients After R0-Resection of Adenocarcinoma of the Stomach and Esophagogastric Junction
Sponsor:
AIO-Studien-gGmbH
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S-1 adjuvant
Brief 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.
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).
Cohort 1 consists of 30 patients who receive S-1 twice daily for 18 cycles (D1-14 q 3 wks).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-004116-11 | EUDRACT_NUMBER | None | View |