The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study|
- Survival [ Time Frame: After 2 years from therapy ] [ Designated as safety issue: Yes ]
Biospecimen Retention: None Retained
Resected stomach specimen of the patients.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
This arm will take a neoadjuvant chemotherapy regimen previous gastrectomy operation.
Surgery will be performed in patients of this arm.
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.
|Haydarpasa Numune Training and Research Hospital|
|Istanbul, Turkey, 34668|
|Principal Investigator:||Atilla Celik, M.D.||Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey|