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The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Atilla Celik, Haydarpasa Numune Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01444755
First received: September 29, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haydarpasa Numune Training and Research Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: After 2 years from therapy ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Resected stomach specimen of the patients.


Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444755

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

No publications provided

Responsible Party: Atilla Celik, Haydarpasa Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01444755     History of Changes
Other Study ID Numbers: HNEAH-01-08
Study First Received: September 29, 2011
Last Updated: September 29, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by 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
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 16, 2013