Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, Peri-operative chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Peri-operative chemotherapy of ECX Type: Drug
Name: Peri-operative chemotherapy of XP Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the safety and the effect of perioperative chemotherapy in the treatment of advanced gastric cancer.
Detailed Description
To evaluate the security and the relapse-free survival time/rate(1,2,3 yrs) of perioperative chemotherapy with ECX (epirubicin + cisplatin + capecitabine) and XP (capecitabine + cisplatin)in advanced gastric cancer
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Male and female aged 18 to 70 years old.

- The preoperative evaluation: 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 and creatinine clearance rate ≥ 60ml/min, LVEF ≥ 60%.

- 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.
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: xiangdong Cheng, MD - +86 571 88122516 - abdsurg@hotmail.com
Start Date
January 2011
Completion Date
June 2013
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page