A Phase 3 interventional study of D2 lymphadenectomy and D2 and #14v lymphadenectomy in Gastric Cancer, sponsored by National Cancer Center, Korea. Status unknown at 12 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by National Cancer Center, Korea · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
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.
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Adequate organ functions defined as indicated below:
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Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm
Procedure: D2 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
Procedure: D2 and #14v 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.
Also known as: Subtotal gastrectomy
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.
Also known as: Subtotal gastrectomy, D2 lymphadenectomy, #14v lymphadenectomy
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
Patients were randomized to an intention-to-treat population. The primary efficacy assessment was performed at the end of the 3-year follow-up period. The free-disease survival rates of the two groups were compared by log rank test.
Time frame: the last recruited patient was followed up for 3 years
Plan to share: No
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National Cancer Center, Korea