A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
20 Years
80 Years
Both
Gastric Cancer
Trial Information
A Multicenter Randomized Phase II Clinical Trial of Laparoscopy Assisted Versus Open Distal Gastrectomy With D2 Lymph Node Dissection for Advanced Gastric Cancer
To test oncological feasibility, compliance of nodal dissection was selected as a primary
end point. When there are more than two missing nodal station(no lymph nodes in dissected
area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be
supplementary to evaluate feasibility of D2 dissection.
Inclusion Criteria:
- histologically proven primary gastric adenocarcinoma
- T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed
tomography (CT) scan - mid 1/3 or low 1/3 location
- No evidence of other distant metastasis
- not stump carcinoma,(vi) aged 20-80 year old
- performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- no prior treatment of chemotherapy or radiation therapy against any other
malignancies, and no prior treatment for gastric cancer including endoscopic mucosal
resection
- adequate organ functions defined as indicated below:
- WBC 3000/mm3, WBC 12 000/mm3
- Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
- Plt 100 000/mm3
- AST 100 IU/l
- ALT 100 IU/l
- T.Bil 2.0 mg/dl
- written informed consent
Exclusion Criteria:
- active double cancer (synchronous double cancer and metachronous double cancer within
five disease-free years), excluding carcinoma in situ (lesions equal to
intraepithelial or intramucosal cancer)
- pregnant or breast-feeding women
- severe mental disorder
- systemic administration of corticosteroids
- unstable angina or myocardial infarction within 6 months of the trial
- unstable hypertension
- severe respiratory disease requiring continuous oxygen therapy
- previous upper abdominal surgery except laparoscopic cholecystectomy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
noncompliance rate
Outcome Description:
A Case will be designated as "noncompliant" when there are more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping
Outcome Time Frame:
postoperative 1 week
Safety Issue:
No
Principal Investigator
Young-Woo Kim, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
NCCCTS-09-448
NCT ID:
NCT01088204
Start Date:
June 2010
Completion Date:
December 2016
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms
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