Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers

NCT03468712 | Unknown DMC

• 1 other identifier: CLASS-03a
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 16

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.

Conditions

Complications, Postoperative; Surgery--Complications; Cancer of Stomach; Chemotherapy Effect

Keywords

mortality; morbidity; neoadjuvant chemotherapy; laparoscopic gastrectomy; gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative mortality rate

  Postoperative 30 days

• R0 resection rate

  The day of surgery

• Completion rate of laparoscopic surgery

  The day of surgery

Study Arms (1)

Experimental group

EXPERIMENTAL

Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy

Procedure: Laparoscopic D2 distal gastrectomy

Interventions

Laparoscopic D2 distal gastrectomy PROCEDURE

Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• West China Hospital: lead
• Peking University Cancer Hospital & Institute: collaborator
• Southern Medical University, China: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Fujian Medical University Union Hospital: collaborator
• Ruijin Hospital: collaborator
• Southwest Hospital, China: collaborator
• RenJi Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Fudan University: collaborator
• Tang-Du Hospital: collaborator
• Harbin Medical University: collaborator
• The First Hospital of Jilin University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (16)

Peking University Cancer Hospital and Institute

Beijing, Beijing Municipality, 10000, China

NOT YET RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Southwest Hospital, the Third Military Medical University

Chongqing, Chongqing Municipality, 404100, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, 51000, China

NOT YET RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Harbin Medical University

Harbin, Heilonngjiang, China

NOT YET RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

NOT YET RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

RenJi Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai JiaoTong University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Tangdu Hospital, Fourth Military Medical University

Xian, Shanxi, 710000, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 26903580 BACKGROUND

• 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.

  PMID: 21060024 BACKGROUND

• 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.

  PMID: 22110287 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jian-Kun Hu, M.D. Ph.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Kun Hu, M.D. Ph.D.

CONTACT

02885422878; hujkwch@126.com

Wei-Han Zhang, M.D. Ph.D.

CONTACT

02885422480

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Department of Gastrointestinal Surgery, West China Hospital

Model Details: Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 16, 2018
• Study Start: March 31, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2023
• Last Updated: September 5, 2018

Record last verified: 2018-03

Locations

CN (16)