Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Peri-operative Chemotherapy With ECX (Epirubicin + Cisplatin + Capecitabine) or XP (Capecitabine + Cisplatin) in the Treatment of Advanced Gastric Cancer: a Randomized, Multicenter, Parallel Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01558947
• Other study ID #: PC-AGC-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 7, 2012
• Last updated: March 18, 2012
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2012
• Source: Zhejiang Cancer Hospital
• Contact: xiangdong Cheng, MD
• Phone: +86 571 88122516
• Email: abdsurg[@]hotmail.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 perioperative chemotherapy in the treatment of advanced gastric cancer.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• 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: 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Peri-operative chemotherapy of ECX
Preoperative chemotherapy of ECX for 3 cycles(Epirubicin 50mg/m2 on day 1; capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2~4 weeks, and postoperative chemotherapy of ECX for 3 cycles 4~6 weeks after surgery.
• Peri-operative chemotherapy of XP
Preoperative chemotherapy of XP for 3 cycles(capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2~4 weeks, and postoperative chemotherapy of XP for 3 cycles 4~6 weeks after 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 relapse-free survival time/rate		3 years	Yes