Trial Information
A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD/pathologic CR
Outcome Time Frame:
at the time of surgery
Safety Issue:
Yes
Principal Investigator
Won Ki Kang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
2008-06-013
NCT ID:
NCT01106066
Start Date:
March 2009
Completion Date:
November 2012
Related Keywords:
- 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
- Stomach Neoplasms