D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
surgery
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, surgery, surgery safety, effect
Eligibility Criteria
Inclusion Criteria:
- Male and female aged 18 to 70 years old.
- The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
- Karnofsky score ≥ 70, life expectancy > 6 months.
- Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
- the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3;
- GOT, GPT within twice the institutional limit,serum total bilirubin < 1.5 times the upper limit of normal, serum creatinine< 1.25 times the upper limit of normal
- have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent.
- must accept the standard D2 or D2 + radical gastrectomy.
- with good compliance.
Exclusion Criteria:
- pregnancy, breast-feeding women.
- allergy with chemotherapy drugs or metabolic disorder.
- the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
- had long received systemic steroid treatment (Note: short-term users of withdrawal > 2 weeks can be selected.)
- The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
- patients with severe infection requires treatment.
- patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
- with other malignancies which were not cured.
- EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
D2 surgery
D2+ surgery
Arm Description
D2 surgery(No.1、No.3、No.4sb、No.4d、No.5、No.6、No.7 and No.8a、No.9、No.11p、No.12a lymph node)
D2+ surgery(D2+8p、12b、13、14v lymph node)
Outcomes
Primary Outcome Measures
the disease-free survival time
the overall survival time
Secondary Outcome Measures
Full Information
NCT ID
NCT01836991
First Posted
April 17, 2013
Last Updated
April 22, 2013
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01836991
Brief Title
D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Official Title
Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.
Detailed Description
To evaluate the safety and the disease-free survival time(DFS) and overall survival time(OS) of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, surgery, surgery safety, effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D2 surgery
Arm Type
Other
Arm Description
D2 surgery(No.1、No.3、No.4sb、No.4d、No.5、No.6、No.7 and No.8a、No.9、No.11p、No.12a lymph node)
Arm Title
D2+ surgery
Arm Type
Experimental
Arm Description
D2+ surgery(D2+8p、12b、13、14v lymph node)
Intervention Type
Procedure
Intervention Name(s)
surgery
Primary Outcome Measure Information:
Title
the disease-free survival time
Time Frame
3 years
Title
the overall survival time
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female aged 18 to 70 years old.
The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
Karnofsky score ≥ 70, life expectancy > 6 months.
Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3;
GOT, GPT within twice the institutional limit,serum total bilirubin < 1.5 times the upper limit of normal, serum creatinine< 1.25 times the upper limit of normal
have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent.
must accept the standard D2 or D2 + radical gastrectomy.
with good compliance.
Exclusion Criteria:
pregnancy, breast-feeding women.
allergy with chemotherapy drugs or metabolic disorder.
the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
had long received systemic steroid treatment (Note: short-term users of withdrawal > 2 weeks can be selected.)
The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
patients with severe infection requires treatment.
patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
with other malignancies which were not cured.
EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiangdong Cheng, MD
Phone
+86 571 88122516
Email
ypfzmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiangdong Cheng
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou,
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangdong Cheng
Phone
+86 571 88122516
Email
ypfzmu@163.com
First Name & Middle Initial & Last Name & Degree
xiangdong Cheng
12. IPD Sharing Statement
Citations:
PubMed Identifier
31747885
Citation
Xu ZY, Hu C, Chen S, Du YA, Huang L, Yu PF, Wang LJ, Cheng XD. Evaluation of D2-plus radical resection for gastric cancer with pyloric invasion. BMC Surg. 2019 Nov 20;19(1):172. doi: 10.1186/s12893-019-0605-6.
Results Reference
derived
PubMed Identifier
30728027
Citation
Yu P, Du Y, Xu Z, Huang L, Cheng X. Comparison of D2 and D2 plus radical surgery for advanced distal gastric cancer: a randomized controlled study. World J Surg Oncol. 2019 Feb 6;17(1):28. doi: 10.1186/s12957-019-1572-1.
Results Reference
derived
Learn more about this trial
D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
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