gastric cancer
Conditions
Interventions
Open distal gastrectomy with D2 lymph node dissection
Laparoscopic distal gastrectomy with D2 lymph node dissection
Sponsors
non-profit organization KSATTS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1st enrollment i. Histologically proven adenocarcinoma of the stomach ii.Clinical T4aN0-N3 disease, confirmed by upper gastrointestinal endoscopy or an upper gastrointestinal series, and abdominal CT and laparoscopy. iii.The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved. iv.No bulky lymph node metastasis is detected by abdominal CT v.No metastasis to the lung, mediastinal lymph nodes, or the other distant organs, confirmed by thoracic CT for tumors invading the esophagus. vi.No clinically apparent distant metastasis vii.Age ranging between 20 and 80. viii.ECOG performance status 0-1 ix.Enough oral intake x.No previous treatment with chemotherapy or radiation therapy for any tumors xi.No previous surgery for the present disease except bypass surgery xii.The patients were enrolled in the COMPASS-D phase 2 trial comparing neoadjuvant chemotherapy with 2 and 4 courses of S-1 plus cisplatin (SC) or S-1 plus cisplatin and docetaxel (SCD) by a two by a two factorial design for patients with macroscopically resectable serosa-positive gastric cancer, and receive neoadjuvant chemotherapy. xiii.Written informed consent. 2nd enrollment i.Patients received 2 or 4 courses of SC or SCD defined by the COMPASS-D trial. ii.The gastric tumors are macroscopically resectable disease by distal gastrectomy with D2 lymph node dissection. Resectability are evaluated by upper gastrointestinal endoscopy and CT 7 to 21 days after the date when the anti-cancer drugs were given. iii.No T4b disease iv.No bulky lymph node metastasis v.Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anti-cancer drugs were given. vi.No need for emergency surgery due to bleeding or perforation of the primary tumor vii.No need for emergency surgery due to stenosis viii.No mechanical obstruction
Exclusion criteria
Exclusion criteria: i.Past history of upper-abdominal surgery ii.Past history of surgery for the gastrointestinal tract iii.Body mass index exceeding 30 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year overall survival rate Treatment-related death | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival overall survival after 1st endollment surgical morbidity and mortality, R0 resection rate, R0R1 resection rate, conversion rate, efficacy and safety in patients who complete the surgery efficacy and safety in each subset. | — |
Countries
Japan
Contacts
Public ContactTakaki Yoshikawa
Yokohama City University Medical Center Department of Gastrointestinal Surgery
Outcome results
None listed