D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer

Phase 2

• Conditions: Gastric Cancer
• Interventions: Procedure: surgery

• Registration Number: NCT01836991
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-22
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23
• Primary Completion: 2014-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D2 surgery	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)
D2+ surgery	surgery	D2+ surgery(D2+8p、12b、13、14v lymph node)

Primary Outcome Measures

Name	Time	Method
the overall survival time	3 years
the disease-free survival time	3 years

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou,, Zhejiang, China