The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
NCT ID: NCT01444755
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2009-01-31
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1-Neoadjuvant Chemotherapy
This arm will take a neoadjuvant chemotherapy regimen previous gastrectomy operation.
No interventions assigned to this group
2 Surgery
Surgery will be performed in patients of this arm.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy or lactation in female patients
* Any immunosuppressive condition (acquired or iatrogenic)
* Any infectious toxic or mental condition preventing neoadjuvant therapy
18 Years
90 Years
ALL
No
Sponsors
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Haydarpasa Numune Training and Research Hospital
OTHER
Responsible Party
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Atilla Celik
Atilla Celik
Principal Investigators
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Atilla Celik, M.D.
Role: PRINCIPAL_INVESTIGATOR
Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey
Locations
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Haydarpasa Numune Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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HNEAH-01-08
Identifier Type: -
Identifier Source: org_study_id