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The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01444755
Recruitment Status : Unknown
Verified September 2011 by Atilla Celik, Haydarpasa Numune Training and Research Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 3, 2011
Last Update Posted : October 3, 2011
Sponsor:
Information provided by (Responsible Party):
Atilla Celik, Haydarpasa Numune Training and Research Hospital

September 29, 2011
October 3, 2011
October 3, 2011
January 2009
December 2011   (Final data collection date for primary outcome measure)
Survival [ Time Frame: After 2 years from therapy ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
Resected stomach specimen of the patients.
Probability Sample
Primary care clinic
Gastric Cancer
Not Provided
  • 1-Neoadjuvant Chemotherapy
    This arm will take a neoadjuvant chemotherapy regimen previous gastrectomy operation.
  • 2 Surgery
    Surgery will be performed in patients of this arm.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
Same as current
April 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01444755
HNEAH-01-08
No
Not Provided
Not Provided
Atilla Celik, Haydarpasa Numune Training and Research Hospital
Haydarpasa Numune Training and Research Hospital
Not Provided
Principal Investigator: Atilla Celik, M.D. Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey
Haydarpasa Numune Training and Research Hospital
September 2011