Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
NCT ID: NCT03264807
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
518 participants
INTERVENTIONAL
2015-08-06
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D2 lymphadenectomy
Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm
D2 lymphadenectomy
Subtotal gastrectomy with D2 lymphadenectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) is conventional surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
D2 and #14v lymphadenectomy
Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and lymph node #14v lymphadnectomy could be performed in this arm
D2 and #14v lymphadenectomy
Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and #14v lymphadenectomy is experimental surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
Interventions
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D2 lymphadenectomy
Subtotal gastrectomy with D2 lymphadenectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) is conventional surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
D2 and #14v lymphadenectomy
Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and #14v lymphadenectomy is experimental surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. WBC 3000/mm3 - 12,000/mm3
2. \> Serum Hemoglobin 8.0 g/dl
3. \> Serum Platelet 100 000/mm3
4. \< Serum AST 100 IU/l
5. \<Serum ALT 100 IU/l
6. \< Total Bilirubin 2.0 mg/dl
* Written signed informed consent
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Hong Man Yoon
Principal Investigator
Principal Investigators
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HONG MAN YOON, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Locations
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The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon, Bupyeong-gu, South Korea
Dongnam Inst. of Radiological & Medical Sciences
Busan, Gijang-gun, South Korea
Gyeongsang national university hospital
Gyeongsang, Gingu-si, South Korea
National Cancer Center
Gyeonggi-do, Goyang-si, South Korea
catholic university of korea,Seoul ST. Mary's Hospital.
Seocho, Seoul, South Korea
Severance Hospital
Seoul, Sincon, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
A JOU University medical center
Gyeonggi-do, Suwon-si, South Korea
Pusan National University Yangsan Hospital
Gyeongsang, Yangsan-si, South Korea
Gyeongsang National University Changwon hospital
Changwon, , South Korea
Dankook University Hospital
Cheonan, , South Korea
The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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taehwan [email protected]
Role: backup
Other Identifiers
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NCC2015-0188
Identifier Type: -
Identifier Source: org_study_id
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