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A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
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

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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

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