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)
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center Identifier:
First received: April 15, 2010
Last updated: June 12, 2013
Last verified: June 2013

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:

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 ]

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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01106066

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

No publications provided

Responsible Party: Won Ki Kang, Professor, Samsung Medical Center Identifier: NCT01106066     History of Changes
Other Study ID Numbers: 2008-06-013
Study First Received: April 15, 2010
Last Updated: June 12, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014