Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer

National Cancer Center (NCC)

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer

Treatments: Procedure: D2 and #14v lymphadenectomy; Procedure: D2 lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03264807

NCC2015-0188

Details and patient eligibility

About

The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.

Full 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.

Enrollment: 518 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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518 participants in 2 patient groups

D2 lymphadenectomy

Active Comparator group

Description:

Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm

Treatment:

Procedure: D2 lymphadenectomy

D2 and #14v lymphadenectomy

Experimental group

Description:

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

Treatment:

Procedure: D2 and #14v lymphadenectomy