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

Samsung Medical Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin; Phase I: To Determine the Maximum Tolerated Dose (MTD)

Treatments: Drug: Oxaliplatin, S-1, radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01106066

2008-06-013

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

S-1/oxaliplatin/RT

Experimental group

Description:

Radiotherapy + 4 dose levels of oxaliplatin/S-1

Treatment:

Drug: Oxaliplatin, S-1, radiotherapy