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

Phase I: To Determine the Maximum Tolerated Dose (MTD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01106066
• Other study ID #: 2008-06-013
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 15, 2010
• Last updated: June 12, 2013
• Start date: March 2009
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years

• Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ? Localized gastric cancer of clinical stage (T2N(+), T3/T4)

• ECOG performance status of 0 to 1 ? 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 ? Written informed consent form

Exclusion Criteria:

• T1 (regardless of N stage), T2N0

• M1 ? Peritoneal seeding ? Uncontrolled medical condition

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Cancer Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD/pathologic CR		at the time of surgery	Yes