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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

This study is currently recruiting participants.
Verified January 2012 by Samsung Medical Center
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01106066
First received: April 15, 2010
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • MTD/pathologic CR [ Time Frame: at the time of surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: March 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106066

Contacts
Contact: Hyejin Jang, RN 822-3410-6859 hyejin1217.jang@samsung.com

Locations
Korea, Republic of
Samsung Cancer Center Recruiting
Seoul, Korea, Republic of
Contact: Hyejin Jang, RN     822-3410-6859     hyejin1217.jang@samsung.com    
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won Ki Kang, MD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01106066     History of Changes
Other Study ID Numbers: 2008-06-013
Study First Received: April 15, 2010
Last Updated: January 18, 2012
Health Authority: Korea: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013