The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer
Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedOctober 3, 2011
September 1, 2011
2.9 years
September 29, 2011
September 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
After 2 years from therapy
Study Arms (2)
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.
Eligibility Criteria
Primary care clinic
You may qualify if:
- Histologically proven adenocarcinoma of stomach
- T3 or T4
- N1 or N2
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haydarpasa Numune Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
Biospecimen
Resected stomach specimen of the patients.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Atilla Celik, M.D.
Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Atilla Celik
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 3, 2011
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
October 3, 2011
Record last verified: 2011-09