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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-11-30

Brief Summary

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

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-1/oxaliplatin/RT

Radiotherapy + 4 dose levels of oxaliplatin/S-1

Group Type EXPERIMENTAL

Oxaliplatin, S-1, radiotherapy

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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