Clinical trial NCT03264807: Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
Official title: A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Lymph Node 14v
D2 lymphadenectomy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2017-08-29
Enrollment: 518
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 is excluded from the study. In a retrospective study conducted in our hospital, we compared the patients with the 14v lymphadenectomy group and those without the 14v lymphadenectomy group, the survival rate of the 14v lymphadenectomy group was 11% higher than that of the 14v non-lymphadenectomy group.Previous studies have suggested that the presence of metastatic lymph nodes in the 14v lymph node is not good and that removal of the 14v lymph node does not affect prognosis. However, if the lymph node is a continuous tissue and the transition to the 14v lymph node is confirmed microscopically, a negative prognosis may be expected because it is likely that the cancer has spread to the distal lymph node. In addition, inadequate resection of the lymphatic or 14v lymph node adjacent to the 14v lymph node in the absence of evidence of metastasis of the 14v lymph node under microscopic examination indicates that cancer may spread even after curative surgery, To prevent cancer metastasis.

Eligibility criteria: \<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:

  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\>

* 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

Primary outcomes:
measure: Superiority verification of disease-free survival after lymphadenectomy for D2 + 14v lymph node dissection in gastric resection in patients with T3N + and T4N + stomach cancer
timeFrame: the last recruited patient was followed up for 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary'S Hospital
state: Bupyeong-gu
city: Busan
country: Korea, Republic of
facility: Dongnam Inst. of Radiological & Medical Sciences
state: Gijang-gun
city: Gyeongsang
country: Korea, Republic of
facility: Gyeongsang national university hospital
state: Gingu-si
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
state: Goyang-si
city: Seocho
country: Korea, Republic of
facility: catholic university of korea,Seoul ST. Mary's Hospital.
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Sincon
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Gyeonggi-do
country: Korea, Republic of
facility: A JOU University medical center
state: Suwon-si
city: Gyeongsang
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Yangsan-si
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Incheon
country: Korea, Republic of
facility: The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
Study officials:
affiliation: National Cancer Center
name: HONG MAN YOON, MD
role: PRINCIPAL_INVESTIGATOR
References: