The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

Detailed Description
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Adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. Radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in Japan and Asian centers. Unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (R0) resection. Moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country. Additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence. In this reason, we hypothesize that preoperative chemotherapy may improve the R0 resection rate or disease free and/or overall survival rate.

Official Title
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Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study

Conditions
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Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of stomach T3 or T4 N1 or N2 M0 No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or Krukenberg tumor. No involvement of the esophagus with > 2cm An age of 18-90 years A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status (0-2) No previous chemotherapy, radiotherapy for any malignancy. No previous surgery for gastric cancer No evidence obstructive or bleeding symptoms. Adequate renal and hepatic function Written informed consent Exclusion Criteria: Synchronous or metachronous malignancy diagnosing within 5 year Pregnancy or lactation in female patients Any immunosuppressive condition (acquired or iatrogenic) Any infectious toxic or mental condition preventing neoadjuvant therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-Neoadjuvant Chemotherapy<br>This arm will take a neoadjuvant chemotherapy regimen previous gastrectomy operation. | |
| 2 Surgery<br>Surgery will be performed in patients of this arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | After 2 years from therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced gastric cancer, neoadjuvant chemotherapy