The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
This trial is active, not recruiting.
|Sponsor||Haydarpasa Numune Training and Research Hospital|
|Start date||January 2009|
|End date||December 2011|
|Trial size||80 participants|
|Trial identifier||NCT01444755, HNEAH-01-08|
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.
|Observational model||case control|
This arm will take a neoadjuvant chemotherapy regimen previous gastrectomy operation.
Surgery will be performed in patients of this arm.
time frame: After 2 years from therapy
Male or female participants from 18 years up to 90 years old.
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
|Official title||Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study|
|Principal investigator||Atilla Celik, M.D.|
|Description||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.|
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