Back to resultsPhase 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
Primary Purpose
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
Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxaliplatin, S-1, radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Phase I: To Determine the Maximum Tolerated Dose (MTD)
Eligibility Criteria
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
Sites / Locations
- Samsung Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-1/oxaliplatin/RT
Arm Description
Radiotherapy + 4 dose levels of oxaliplatin/S-1
Outcomes
Primary Outcome Measures
MTD/pathologic CR
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01106066
Brief Title
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
Official Title
A Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting patients
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-1/oxaliplatin/RT
Arm Type
Experimental
Arm Description
Radiotherapy + 4 dose levels of oxaliplatin/S-1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin, S-1, radiotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
MTD/pathologic CR
Time Frame
at the time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Ki Kang, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Cancer Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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