We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Difficulties in recruiting patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106066
First Posted: April 19, 2010
Last Update Posted: June 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
  Purpose
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer

Condition Intervention Phase
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 Drug: Oxaliplatin, S-1, radiotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Won Ki Kang, Samsung Medical Center:

Primary Outcome Measures:
  • MTD/pathologic CR [ Time Frame: at the time of surgery ]

Enrollment: 30
Study Start Date: March 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1/oxaliplatin/RT
Radiotherapy + 4 dose levels of oxaliplatin/S-1
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years

    • Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)

      • ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form

Exclusion Criteria:

  • T1 (regardless of N stage), T2N0

    • M1 ③ Peritoneal seeding ④ Uncontrolled medical condition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106066


Locations
Korea, Republic of
Samsung Cancer Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
  More Information

Responsible Party: Won Ki Kang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01106066     History of Changes
Other Study ID Numbers: 2008-06-013
First Submitted: April 15, 2010
First Posted: April 19, 2010
Last Update Posted: June 14, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents