The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01444755
• Other study ID #: HNEAH-01-08
• Status: Active, not recruiting
• Phase: N/A
• First received: September 29, 2011
• Last updated: September 29, 2011
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: September 2011
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		After 2 years from therapy	Yes