The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Atilla Celik, 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.

Condition or disease
Gastric Cancer

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 Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
Study Start Date : January 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.

Primary Outcome Measures :
  1. Survival [ Time Frame: After 2 years from therapy ]

Biospecimen Retention:   None Retained
Resected stomach specimen of the patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444755

Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey, 34668
Sponsors and Collaborators
Haydarpasa Numune Training and Research Hospital
Principal Investigator: Atilla Celik, M.D. Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey

Responsible Party: Atilla Celik, Haydarpasa Numune Training and Research Hospital Identifier: NCT01444755     History of Changes
Other Study ID Numbers: HNEAH-01-08
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Keywords provided by Atilla Celik, Haydarpasa Numune Training and Research Hospital:
Locally advanced gastric cancer
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases