Preoperative Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma

Study Overview
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Brief Summary
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Gastric cancer is a high incidence in Asia, and one of the leading cause of death in Korea. A cure rate is improving due to early diagnosis. However, the 5-year survival rate of gastric cancer excluding early gastric cancer is about 40   67%. Therefore, several methods for lowering the recurrence rate have been attempted and concurrent chemoradiotherapy can be considered as a method to lower the recurrence rate of gastric cancer. The purpose of this study is to evaluate the pathologic response rate and safety of patients who underwent surgery after chemoradiotherapy.

Official Title
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Preoperative S-1 Plus Cisplatin-based Chemoradiotherapy for Locally Advanced Resectable Gastric Adenocarcinoma : Randomized, Phase II Trial

Conditions
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Gastric Adenocarcinoma

Intervention / Treatment
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* Drug: TS-1 + cisplatin
* Radiation: radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 years old Histologically confirmed gastric adenocarcinoma clinical stage : resectable gastric cancer advanced confirmed (EGD) extramural infiltration> 1 mm (CT) positive serosa invasion (EUS) Eastern Cooperative Oncology Group performance status 0 or 1 no prior chemotherapy and radiotherapy measurable lesion or evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria Patients with adequate organ function Signed informed consent Exclusion Criteria: Metastasis esophageal invasion > 3cm inoperable peritoneal seeding disease determined by exploratory laparotomy T4b invading the surrounding organs lymph node metastasis outside the celiac trunk Lymph node and splenic lymph node uncontrolled viral infections (HIV, HBV, HCV) Pregnant or lactating women, women of childbearing potential not employing adequate contraception severe hypersensitivity reactions to S-1, cisplatin Subjects with uncontrolled clinically significant cardiovascular medical history, uncontrolled infection or complication Other co-existing malignancies or malignancies diagnosed within the last 5 years except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP+CCRT<br>S-1 20mg/m2, bid (D1 14, D22 35) Cisplatin 30mg/m2/day (W1, 2, 4, 5) radiation 45Gy per 5 weeks | Drug: TS-1 + cisplatin<br>* S-1 20mg/m2, bid (D1 14, D22 35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)<br>Radiation: radiation<br>* radiation 45Gy per 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological response rate | to evaluate pathological response rate in locally advanced resectable gastric cancer | 10 week |