Overview

This trial is active, not recruiting.

Condition gastric cancer
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
This arm will take a neoadjuvant chemotherapy regimen previous gastrectomy operation.
Surgery will be performed in patients of this arm.

Primary Outcomes

Measure
Survival
time frame: After 2 years from therapy

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Haydarpasa Numune Training and Research Hospital.