Chemotherapy Effect Clinical Trial
— CLASS-03aOfficial title:
Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers: A Prospective Multicenter Trial
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.
Status | Recruiting |
Enrollment | 166 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 Exclusion Criteria 1. History of upper abdominal surgery (include endoscopic mucosal resection or endoscopic submucosal dissection, except for laparoscopic cholecystectomy); 2. History of acute pancreatitis; 3. Enlarged or bulky regional lymph node (diameter>3cm) by imaging exam; 4. Patients have received neoadjuvant therapy prior to screen work; 5. History of other malignant disease within the past five years; 6. History of cerebrovascular accident within the past six months; 7. History of continuous systematic administration of corticosteroids within the past month; 8. Scheduled simultaneous surgery for other disease; 9. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer; 10. Pyloric obstruction; 11. FEV1<50% of predicted value; 12. Women who are pregnant or lactating at the time of screening; 13. Severe mental disorder; 14. Participating in other clinical studies; 15. Refused to sign the informed consent; - Second Round Exclusion Criteria 1. 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 2. Patients cannot complete 3 cycles of chemotherapy due to intolerance; 3. After 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate surgery due to severe adverse reactions, or ASA score = 4 ; 4. Patients undertake emergency operation due to tumor bleeding, perforation or obstruction during chemotherapy; 5. After signing the informed consent, the patient withdraws from this clinical trial. Withdrawal Criteria After Second Round: 1. Intro-abdominal metastasis of primary cancer is revealed intraoperatively; 2. Primary cancer is confirmed to be un-resectable intraoperatively. |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
China | Peking University Cancer Hospital and Institute | Beijing | Beijing |
China | First Hospital of Jilin University | Changchun | Jilin |
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
China | Southwest Hospital, the Third Military Medical University | Chongqing | Chongqing |
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
China | Guangdong General Hospital | Guangzhou | Guangdong |
China | Nanfang Hospital | Guangzhou | Guangdong |
China | Sir Run Run Shaw Hospital, Zhejiang University | Hangzhou | Zhejiang |
China | Harbin Medical University | Harbin | Heilonngjiang |
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
China | RenJi Hospital, Shanghai Jiaotong University | Shanghai | Shanghai |
China | Ruijin Hospital, Shanghai JiaoTong University | Shanghai | Shanghai |
China | Zhongshan Hospital, Fudan University | Shanghai | Shanghai |
China | Tangdu Hospital, Fourth Military Medical University | Xian | Shanxi |
Lead Sponsor | Collaborator |
---|---|
West China Hospital | Beijing Cancer Hospital, Chinese PLA General Hospital, First Hospital of Jilin University, Fudan University, Fujian Medical University Union Hospital, Guangdong General Hospital, Harbin Medical University, RenJi Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, Southern Medical University, China, Southwest Hospital, China, Tang-Du Hospital, The First Affiliated Hospital with Nanjing Medical University |
China,
Chen XZ, Yang K, Liu J, Chen XL, Hu JK. Neoadjuvant plus adjuvant chemotherapy benefits overall survival of locally advanced gastric cancer. World J Gastroenterol. 2011 Oct 28;17(40):4542-4. doi: 10.3748/wjg.v17.i40.4542. — View Citation
Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22. — View Citation
Schuhmacher C, Gretschel S, Lordick F, Reichardt P, Hohenberger W, Eisenberger CF, Haag C, Mauer ME, Hasan B, Welch J, Ott K, Hoelscher A, Schneider PM, Bechstein W, Wilke H, Lutz MP, Nordlinger B, Van Cutsem E, Siewert JR, Schlag PM. Neoadjuvant chemotherapy compared with surgery alone for locally advanced cancer of the stomach and cardia: European Organisation for Research and Treatment of Cancer randomized trial 40954. J Clin Oncol. 2010 Dec 10;28(35):5210-8. doi: 10.1200/JCO.2009.26.6114. Epub 2010 Nov 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative overall morbidity rate | 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. | Postoperative 30 days | |
Secondary | Postoperative mortality rate | 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. | Postoperative 30 days | |
Secondary | R0 resection rate | 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.). | The day of surgery | |
Secondary | Completion rate of laparoscopic 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. | The day of surgery |
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