Cancer of Stomach, Chemotherapy Effect, Complications, Postoperative, Surgery--Complications
Conditions
Keywords
mortality, morbidity, neoadjuvant chemotherapy, laparoscopic gastrectomy, gastric cancer
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. The neoadjuvant chemotherapy (NAC) can bring the survival advantage for gastric cancer patients with locally advanced tumor stage. The primary goal of NAC is to control the micrometastasis and/or progression of the primary lesion in order to improve potential of radical gastrectomy. NAC is recommended for patients with locally advanced stage (T2-4Nx) according to the latest NCCN Gastric Cancer Guidelines. Laparoscopy distal gastrectomy (LDG) can achieve a better postoperative short-term recovery than the traditional open distal gastrectomy (ODG), which can reduce the intraoperative blood loss and to shorten the postoperative hospital stay. Therefore, Enhanced Recovery After Surgery program of gastric cancer surgery recommends the use of minimally invasive surgery. For long-term survival outcomes, there is limited evidence supported that laparoscopic gastrectomy is comparable open gastrectomy. Therefore, due to the lack of high-quality prospective clinical trial results, whether advanced tumor is suitable for laparoscopic surgery is still controversial. Therefore, some multi-center prospective randomized controlled trials have been carried out, compared safety and long-term survival outcome between laparoscopic and open gastrectomy in locally advanced gastric cancer patients. CLASS-01 trials reported that for locally advanced gastric cancers, laparoscopic D2 distal gastrectomy is safe and feasible. Patient's surgical tolerance and stress response may be inhibited after the treatment of NAC. The aim of this trial is to confirm the safety of laparoscopy distal D2 radical gastrectomy for the treatment of after neoadjuvant chemotherapy gastric cancer patients (cT3-4a, N+, M0) in terms of postoperative complications.
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 advanced gastric cancer (cT3-4a, N-/+, M0) after neoadjuvant chemotherapy.
Interventions
PROCEDURELaparoscopic D2 distal gastrectomy
Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy
Sponsors
Peking University Cancer Hospital & Institute
Southern Medical University, China
Shanghai Zhongshan Hospital
Chinese PLA General Hospital
Fujian Medical University Union Hospital
Ruijin Hospital
Southwest Hospital, China
RenJi Hospital
The First Affiliated Hospital with Nanjing Medical University
Fudan University
Tang-Du Hospital
Harbin Medical University
The First Hospital of Jilin University
Guangdong Provincial People's Hospital
Sir Run Run Shaw Hospital
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* First Round Inclusion Criteria 1. Age from over 18 to under 75 years; 2. Primary gastric adenocarcinoma (including pap, tub, muc, sig, and por) confirmed pathologically by endoscopic biopsy; 3. cT3-4a, N-/+, M0 according to the AJCC 8th Cancer Staging Manual; 4. Without peritoneal metastasis (examined by laparoscopic examination); 5. Radical resection (R0) through distal subtotal gastrectomy with D2 lymphadenectomy is anticipated; 6. Performance status 0 or 1 (Eastern Cooperative Oncology Group) ; 7. ASA (American Society of Anesthesiology) score ≤ 3; 8. Normal hemodynamic indices: <!-- --> 1. Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L; 2. 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 1. 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; 2. Subjects are still willing to continue participating in this clinical trial.
Exclusion criteria
* First Round
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative overall morbidity rate | Postoperative 30 days | The proportion value will be calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment as the denominator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative mortality rate | Postoperative 30 days | Mortality will be calculated as the ratio between the number of patients who died as numerator and number of all patients undergoing surgical treatment as the denominator. |
| R0 resection rate | The day of surgery | Number of patients underwent gastrectomy for the denominator, number of R0 resection patients is numerator, the ratio is the R0 resection rate. The definition of R0 resection is according to the Japanese gastric cancer treatment guidelines 2014 (ver. 4)（Gastric Cancer. 2017 Jan;20(1):1-19.）. |
| Completion rate of laparoscopic surgery | The day of surgery | Ratio will be calculated with the number of patients complete the laparoscopic gastrectomy as the numerator, and number of all patients undergoing laparoscopic surgical treatment as the denominator. |
Countries
China
Contacts
Primary ContactJian-Kun Hu, M.D. Ph.D.
Backup ContactWei-Han Zhang, M.D. Ph.D.
Outcome results
None listed