D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
NCT ID: NCT01836991
Last Updated: 2013-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2012-01-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D2 surgery
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)
surgery
D2+ surgery
D2+ surgery(D2+8p、12b、13、14v lymph node)
surgery
Interventions
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surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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xiangdong Cheng
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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RS-ADGC
Identifier Type: -
Identifier Source: org_study_id
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