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

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ClinicalTrials.gov Identifier: NCT01836991
Recruitment Status : Unknown
Verified April 2013 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : April 22, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: surgery Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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)
Procedure: surgery
Experimental: D2+ surgery
D2+ surgery(D2+8p、12b、13、14v lymph node)
Procedure: surgery



Primary Outcome Measures :
  1. the disease-free survival time [ Time Frame: 3 years ]
  2. the overall survival time [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836991


Contacts
Contact: xiangdong Cheng, MD +86 571 88122516 ypfzmu@163.com

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou,, Zhejiang, China, 310022
Contact: xiangdong Cheng    +86 571 88122516    ypfzmu@163.com   
Principal Investigator: xiangdong Cheng         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: xiangdong Cheng Zhejiang Cancer Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01836991     History of Changes
Other Study ID Numbers: RS-ADGC
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Zhejiang Cancer Hospital:
gastric cancer
surgery
surgery safety
effect

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases