Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
18 Years
90 Years
Both
Gastric Cancer
Trial Information
Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Survival
Outcome Time Frame:
After 2 years from therapy
Safety Issue:
Yes
Principal Investigator
Atilla Celik, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Haydarpasa Numune Teaching & Research Hospital, Affiliated by Ministery of Health of Turkey
Authority:
Turkey: Ministry of Health
Study ID:
HNEAH-01-08
NCT ID:
NCT01444755
Start Date:
January 2009
Completion Date:
April 2012
Related Keywords:
- Gastric Cancer
- Locally advanced gastric cancer
- neoadjuvant chemotherapy
- Stomach Neoplasms
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