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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

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ClinicalTrials.gov Identifier: NCT01106066
Recruitment Status : Terminated (Difficulties in recruiting patients)
First Posted : April 19, 2010
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : March 2009
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: April 19, 2010    Key Record Dates
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