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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 has been terminated.
(Difficulties in recruiting patients)
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01106066
First received: April 15, 2010
Last updated: June 12, 2013
Last verified: June 2013

April 15, 2010
June 12, 2013
March 2009
November 2012   (final data collection date for primary outcome measure)
MTD/pathologic CR [ Time Frame: at the time of surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01106066 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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)
Experimental: S-1/oxaliplatin/RT
Radiotherapy + 4 dose levels of oxaliplatin/S-1
Intervention: Drug: Oxaliplatin, S-1, radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01106066
2008-06-013
No
Won Ki Kang, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
Samsung Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP