Status:
UNKNOWN
Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Gastric Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
Detailed Description
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection. Actually, if the 14v lymph node metastasis is suspected before surgery, it ...
Eligibility Criteria
Inclusion
- \<Inclusion Criteria\>
- Histologically proven primary gastric adenocarcinoma
- T3N+, T4N+ by CT scan (AJCC 7th classification)
- Distal margin of gastric cancer Location of distal margin of gastric cancer ; antrum, or angle of the stomach
- No evidence of other distant metastasis
- Age ≥ 20 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 - 12,000/mm3
- \> Serum Hemoglobin 8.0 g/dl
- \> Serum Platelet 100 000/mm3
- \< Serum AST 100 IU/l
- \<Serum ALT 100 IU/l
- \< Total Bilirubin 2.0 mg/dl
- Written signed 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)
- Gastric remnant cancer
- Pregnant or breast-feeding women
- Mental disorder(diagnosed with mental disorder on medical record)
- Systemic administration of corticosteroids(include Herbal Medication)
- Unstable angina or myocardial infarction within 6 months of the trial
- Unstable hypertension
- Severe respiratory disease requiring continuous oxygen therapy
- Indications Total gastrectomy
- Borrmann type IV in the preoperative examination (including localized)
- Suspected LN # 14v metastasis during surgery
- Indications Pancreatectomy
- Suspected a metastasis of CT scans LN # 13, LN # 14
- Clinical stage IV group is suspected or confirmed during surgery
Exclusion
Key Trial Info
Start Date :
August 6 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT03264807
Start Date
August 6 2015
End Date
December 31 2021
Last Update
March 3 2020
Active Locations (12)
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1
The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon, Bupyeong-gu, South Korea, 21431
2
Dongnam Inst. of Radiological & Medical Sciences
Busan, Gijang-gun, South Korea, 46033
3
Gyeongsang national university hospital
Gyeongsang, Gingu-si, South Korea, 52727
4
National Cancer Center
Gyeonggi-do, Goyang-si, South Korea, 10408