Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Survival
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proven adenocarcinoma of stomach
- •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
Outcomes
Primary Outcomes
Survival
Time Frame: After 2 years from therapy
Secondary Outcomes
No secondary outcomes reported
Investigators
Atilla Celik
Atilla Celik
Haydarpasa Numune Training and Research Hospital