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

NCT02564367 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-29

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma,Stomach
  • Adenocarcinoma, Esophagogastric Junction

Interventions

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

Sponsors & Collaborators

  • Nordic Pharma SAS

    collaborator INDUSTRY

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Volker Heinemann, Prof. Dr. · Klinikum der Universität München, Campus Großhadern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-06
Primary Completion
2019-03-01
Completion
2020-03-06

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02564367 on ClinicalTrials.gov