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

Gastric Cancer Clinical Trial

Official title:

Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01836991
• Other study ID #: RS-ADGC
• Status: Recruiting
• Phase: Phase 2
• First received: April 17, 2013
• Last updated: April 22, 2013
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: April 2013
• Source: Zhejiang Cancer Hospital
• Contact: xiangdong Cheng, MD
• Phone: +86 571 88122516
• Email: ypfzmu[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2017
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• surgery

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou,	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the disease-free survival time		3 years	No
Primary	the overall survival time		3 years	No