Back to resultsMulticenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer (CLASS-07)
Primary Purpose
Stomach Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic total gastrectomy
Open total gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Laparoscopic total gastrectomy, Open total gastrectomy
Eligibility Criteria
Inclusion Criteria:
- Aged 18-75 years
- Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
- Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
- Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
- Expected survival > 6 months
- No invasion to Z-line;
- BMI (Body Mass Index) < 30 kg/m2
- No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
- No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
- Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
- Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
- Sufficient organ functions
- Written informed consent
Exclusion Criteria:
- Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
- Women during pregnancy or breast-feeding
- Synchronous or metachronous (within 5 years) malignancies
- Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
- Severe mental disease
- Severe respiratory disease, FEV1 < 50% of predicted
- Severe hepatic and renal dysfunction
- Unstable angina pectoris or history of myocardial infarction within 6 months
- History of cerebral infarction or cerebral hemorrhage within 6 months
- Continuous systemic steroid therapy within 1 month (except for topical use)
- Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
- Patients are participating or have participated in another clinical trial (within 6 months)
Sites / Locations
- ZhongShan hospital FuDan universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic total gastrectomy
Open total gastrectomy
Arm Description
The surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.
The surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.
Outcomes
Primary Outcome Measures
Overall survival
Overall survival (OS) was defined as the time from randomization to death from any cause
Secondary Outcome Measures
3-year overall survival rate
# of patients who are still alive at 3 years out of all study patients
3-year disease free survival rate
# of patients who are free of gastric cancer at 3 years out of all study patients
Early morbidity rate
The early morbidity are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications
Early mortality rate
The early mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative death
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Postoperative recovery course
Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Full Information
NCT ID
NCT04710758
First Posted
January 2, 2021
Last Updated
February 23, 2021
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04710758
Brief Title
Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer
Acronym
CLASS-07
Official Title
Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.
Detailed Description
Gastric cancer is a significant global health problem, especially in East Asia. With an increase in the incidences of proximal gastric cancer over the last decades, the value of total gastrectomy is more emphasized. Laparoscopic total gastrectomy (LTG) has become an attracting option for surgeons due to its well-known advantages. However, more evidence is needed to support the safety and efficacy of LTG in locally advanced gastric cancer.
Recently，a multicenter, open-label, noninferiority, randomized clinical trial (CLASS-02) launched by Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group compared the safety of LTG for clinical stage I gastric cancer with open total gastrectomy (OTG). The overall morbidity and mortality rates were 19.1% in the LTG group and 20.2% in the OTG group, which was not significantly different (rate difference, -1.1%). This study demonstrated that LTG can be safely performed by experienced surgeons for clinical stage I gastric cancer. However, there hasn't been any prospective randomized clinical trial study evaluating the safety and efficacy of LTG in advanced gastric cancer.
This CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between LTG and OTG in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, Laparoscopic total gastrectomy, Open total gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1316 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic total gastrectomy
Arm Type
Experimental
Arm Description
The surgeon will perform LTG with D2 lymphadenectomy for patients enrolled in this group.
Arm Title
Open total gastrectomy
Arm Type
Active Comparator
Arm Description
The surgeon will perform OTG with D2 lymphadenectomy for patients enrolled in this group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic total gastrectomy
Other Intervention Name(s)
Experimental group (LTG)
Intervention Description
LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
Intervention Type
Procedure
Intervention Name(s)
Open total gastrectomy
Other Intervention Name(s)
Control group (OTG)
Intervention Description
OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival (OS) was defined as the time from randomization to death from any cause
Time Frame
3 years
Secondary Outcome Measure Information:
Title
3-year overall survival rate
Description
# of patients who are still alive at 3 years out of all study patients
Time Frame
3 years
Title
3-year disease free survival rate
Description
# of patients who are free of gastric cancer at 3 years out of all study patients
Time Frame
3 years
Title
Early morbidity rate
Description
The early morbidity are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications
Time Frame
30 days
Title
Early mortality rate
Description
The early mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative death
Time Frame
30 days
Title
3-year recurrence pattern
Description
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time Frame
3 years
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-75 years
Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
Expected survival > 6 months
No invasion to Z-line;
BMI (Body Mass Index) < 30 kg/m2
No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
Sufficient organ functions
Written informed consent
Exclusion Criteria:
Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
Women during pregnancy or breast-feeding
Synchronous or metachronous (within 5 years) malignancies
Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
Severe mental disease
Severe respiratory disease, FEV1 < 50% of predicted
Severe hepatic and renal dysfunction
Unstable angina pectoris or history of myocardial infarction within 6 months
History of cerebral infarction or cerebral hemorrhage within 6 months
Continuous systemic steroid therapy within 1 month (except for topical use)
Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
Patients are participating or have participated in another clinical trial (within 6 months)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihong Sun, MD
Phone
86-21-64041990
Email
sun.yihong@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yihong Sun, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZhongShan hospital FuDan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihong Sun, MD
Phone
86-13701735406
Email
sun.yihong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yihong Sun, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30207593
Citation
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
Results Reference
background
PubMed Identifier
30046223
Citation
Yang L, Zheng R, Wang N, Yuan Y, Liu S, Li H, Zhang S, Zeng H, Chen W. Incidence and mortality of stomach cancer in China, 2014. Chin J Cancer Res. 2018 Jun;30(3):291-298. doi: 10.21147/j.issn.1000-9604.2018.03.01.
Results Reference
background
PubMed Identifier
27796514
Citation
Yamashita H, Seto Y, Sano T, Makuuchi H, Ando N, Sasako M; Japanese Gastric Cancer Association and the Japan Esophageal Society. Results of a nation-wide retrospective study of lymphadenectomy for esophagogastric junction carcinoma. Gastric Cancer. 2017 Mar;20(Suppl 1):69-83. doi: 10.1007/s10120-016-0663-8. Epub 2016 Oct 28.
Results Reference
background
PubMed Identifier
25647058
Citation
Liu K, Yang K, Zhang W, Chen X, Chen X, Zhang B, Chen Z, Chen J, Zhao Y, Zhou Z, Chen L, Hu J. Changes of Esophagogastric Junctional Adenocarcinoma and Gastroesophageal Reflux Disease Among Surgical Patients During 1988-2012: A Single-institution, High-volume Experience in China. Ann Surg. 2016 Jan;263(1):88-95. doi: 10.1097/SLA.0000000000001148.
Results Reference
background
PubMed Identifier
8180768
Citation
Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum In: Surg Laparosc Endosc. 2013 Oct;23(5):480.
Results Reference
background
PubMed Identifier
26352529
Citation
Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.
Results Reference
background
PubMed Identifier
27718137
Citation
Katai H, Mizusawa J, Katayama H, Takagi M, Yoshikawa T, Fukagawa T, Terashima M, Misawa K, Teshima S, Koeda K, Nunobe S, Fukushima N, Yasuda T, Asao Y, Fujiwara Y, Sasako M. Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912. Gastric Cancer. 2017 Jul;20(4):699-708. doi: 10.1007/s10120-016-0646-9. Epub 2016 Oct 7.
Results Reference
background
PubMed Identifier
32060757
Citation
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.
Results Reference
background
PubMed Identifier
30829698
Citation
Lee HJ, Hyung WJ, Yang HK, Han SU, Park YK, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Hur H, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Kim MC; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT). Ann Surg. 2019 Dec;270(6):983-991. doi: 10.1097/SLA.0000000000003217.
Results Reference
background
PubMed Identifier
26903580
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.
Results Reference
background
PubMed Identifier
31135850
Citation
Yu J, Huang C, Sun Y, Su X, Cao H, Hu J, Wang K, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Hu Y, Liu H, Zheng C, Li P, Xie J, Liu F, Li Z, Zhao G, Yang K, Liu C, Li H, Chen P, Ji J, Li G; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.
Results Reference
background
PubMed Identifier
19760315
Citation
Kawamura H, Yokota R, Homma S, Kondo Y. Comparison of invasiveness between laparoscopy-assisted total gastrectomy and open total gastrectomy. World J Surg. 2009 Nov;33(11):2389-95. doi: 10.1007/s00268-009-0208-y.
Results Reference
background
PubMed Identifier
24558421
Citation
Wang W, Zhang X, Shen C, Zhi X, Wang B, Xu Z. Laparoscopic versus open total gastrectomy for gastric cancer: an updated meta-analysis. PLoS One. 2014 Feb 18;9(2):e88753. doi: 10.1371/journal.pone.0088753. eCollection 2014.
Results Reference
background
PubMed Identifier
30128720
Citation
Hyung WJ, Yang HK, Han SU, Lee YJ, Park JM, Kim JJ, Kwon OK, Kong SH, Kim HI, Lee HJ, Kim W, Ryu SW, Jin SH, Oh SJ, Ryu KW, Kim MC, Ahn HS, Park YK, Kim YH, Hwang SH, Kim JW, Cho GS. A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03. Gastric Cancer. 2019 Jan;22(1):214-222. doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20.
Results Reference
background
PubMed Identifier
30788750
Citation
Katai H, Mizusawa J, Katayama H, Kunisaki C, Sakuramoto S, Inaki N, Kinoshita T, Iwasaki Y, Misawa K, Takiguchi N, Kaji M, Okitsu H, Yoshikawa T, Terashima M; Stomach Cancer Study Group of Japan Clinical Oncology Group. Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401. Gastric Cancer. 2019 Sep;22(5):999-1008. doi: 10.1007/s10120-019-00929-9. Epub 2019 Feb 20.
Results Reference
background
PubMed Identifier
30285673
Citation
He H, Li H, Su X, Li Z, Yu P, Huang H, Huang C, Ye J, Li Y, Suo J, Yu J, Li G, Xu Z, Zhao G, Cao H, Hu J, Du X, Liu F, Sun Y; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Study on safety of laparoscopic total gastrectomy for clinical stage I gastric cancer: the protocol of the CLASS02-01 multicenter randomized controlled clinical trial. BMC Cancer. 2018 Oct 3;18(1):944. doi: 10.1186/s12885-018-4846-z.
Results Reference
background
PubMed Identifier
32815991
Citation
Liu F, Huang C, Xu Z, Su X, Zhao G, Ye J, Du X, Huang H, Hu J, Li G, Yu P, Li Y, Suo J, Zhao N, Zhang W, Li H, He H, Sun Y; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial. JAMA Oncol. 2020 Oct 1;6(10):1590-1597. doi: 10.1001/jamaoncol.2020.3152.
Results Reference
background
Learn more about this trial
Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer
We'll reach out to this number within 24 hrs