Status:
UNKNOWN
The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
Lead Sponsor:
Haydarpasa Numune Training and Research Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
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
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01444755
Start Date
January 1 2009
End Date
April 1 2012
Last Update
October 3 2011
Active Locations (1)
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1
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey (Türkiye), 34668