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Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT

NCT01106066 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-06-14

No results posted yet for this study

Summary

To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer

Conditions

  • Phase I: To Determine the Maximum Tolerated Dose (MTD)
  • Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin

Interventions

DRUG

Oxaliplatin, S-1, radiotherapy

Radiotherapy 4000cGy/20 fractions S-1 ( )mg/m2 po bid daily during radiotherapy Oxaliplatin at four dose levels (\_\_\_mg/m2 iv weekly x 4 weeks)

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Won Ki Kang, MD · Samsung Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • South Korea

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 NCT01106066 on ClinicalTrials.gov