The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

• Conditions: Gastric Cancer

• Registration Number: NCT01444755
• Lead Sponsor: Haydarpasa Numune Training and Research Hospital

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 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.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2011-09
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-29
• Last Update Submitted: 2011-09-29
• Study First Posted: 2011-10-03
• Last Update Posted: 2011-10-03
• Primary Completion: 2011-12
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	After 2 years from therapy

Trial Locations

Locations (1)

Haydarpasa Numune Training and Research Hospital; 🇹🇷 Istanbul, Turkey