Status:
UNKNOWN
Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers
Lead Sponsor:
West China Hospital
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Southern Medical University, China
Conditions:
Complications, Postoperative
Surgery--Complications
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Gastric cancer is the third major cancer of global cancer-related death. In China, the early diagnosis rate of gastric cancer is relatively low, and most patients are with locally advanced tumor stage...
Detailed Description
This is a prospective, multi-centers, open-label, single-arm study, and the aim of this trial is to evaluate the safety of laparoscopic distal D2 radical gastrectomy for the treatment of locally advan...
Eligibility Criteria
Inclusion
- First Round Inclusion Criteria
- Age from over 18 to under 75 years;
- Primary gastric adenocarcinoma (including pap, tub, muc, sig, and por) confirmed pathologically by endoscopic biopsy;
- cT3-4a, N-/+, M0 according to the AJCC 8th Cancer Staging Manual;
- Without peritoneal metastasis (examined by laparoscopic examination);
- Radical resection (R0) through distal subtotal gastrectomy with D2 lymphadenectomy is anticipated;
- Performance status 0 or 1 (Eastern Cooperative Oncology Group) ;
- ASA (American Society of Anesthesiology) score ≤ 3;
- Normal hemodynamic indices:
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- Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L;
- Liver and renal function: BIL\<1.5 times of the upper limit of normal reference values, ALT and AST\<2.5 times of the upper limit of normal reference values, and Crea≤1 time of upper limits of normal reference values.
- Second Round Inclusion Criteria
- Therapeutic response rating after neoadjuvant chemotherapy is CR, PR, SD, or Therapeutic response rating after neoadjuvant chemotherapy is PD, tumor is expected to have radical resection;
- Subjects are still willing to continue participating in this clinical trial.
Exclusion
- First Round Exclusion Criteria
- History of upper abdominal surgery (include endoscopic mucosal resection or endoscopic submucosal dissection, except for laparoscopic cholecystectomy);
- History of acute pancreatitis;
- Enlarged or bulky regional lymph node (diameter\>3cm) by imaging exam;
- Patients have received neoadjuvant therapy prior to screen work;
- History of other malignant disease within the past five years;
- History of cerebrovascular accident within the past six months;
- History of continuous systematic administration of corticosteroids within the past month;
- Scheduled simultaneous surgery for other disease;
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer;
- Pyloric obstruction;
- FEV1\<50% of predicted value;
- Women who are pregnant or lactating at the time of screening;
- Severe mental disorder;
- Participating in other clinical studies;
- Refused to sign the informed consent;
- Second Round Exclusion Criteria
- Therapeutic response rating after neoadjuvant chemotherapy is PD, involvement of adjacent structures(T4b), distal metastasis(M1), or enlarged or bulky regional lymph node (diameter\>3cm) by preoperative imaging
- Patients cannot complete 3 cycles of chemotherapy due to intolerance;
- After 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate surgery due to severe adverse reactions, or ASA score ≥ 4 ;
- Patients undertake emergency operation due to tumor bleeding, perforation or obstruction during chemotherapy;
- After signing the informed consent, the patient withdraws from this clinical trial.
- Withdrawal Criteria After Second Round:
- Intro-abdominal metastasis of primary cancer is revealed intraoperatively;
- Primary cancer is confirmed to be un-resectable intraoperatively.
Key Trial Info
Start Date :
March 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03468712
Start Date
March 31 2018
End Date
April 30 2023
Last Update
September 5 2018
Active Locations (16)
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1
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, China, 10000
2
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
3
Southwest Hospital, the Third Military Medical University
Chongqing, Chongqing Municipality, China, 404100
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China