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 1
Terminated
- Conditions
- 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
- Interventions
- Drug: Oxaliplatin, S-1, radiotherapy
- Registration Number
- NCT01106066
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description S-1/oxaliplatin/RT Oxaliplatin, S-1, radiotherapy Radiotherapy + 4 dose levels of oxaliplatin/S-1
- Primary Outcome Measures
Name Time Method MTD/pathologic CR at the time of surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Cancer Center
🇰🇷Seoul, Korea, Republic of