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

NCT ID: NCT01558947

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-06-30

Brief 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

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

chemotherapy with ECX

chemotherapy with ECX

Group Type: EXPERIMENTAL

Peri-operative chemotherapy of ECX

Intervention Type: DRUG

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.

chemotherapy with XP

chemotherapy with XP

Group Type: EXPERIMENTAL

Peri-operative chemotherapy of XP

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

ECX chemotherapy; XP chemotherapy

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

xiangdong Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiangdong Cheng, MD

Role: CONTACT

abdsurg@hotmail.com

+86 571 88122516

Facility Contacts

xiangdong Cheng, MD

Role: primary

abdsurg@hotmail.com

+86 571 88122516

Other Identifiers

PC-AGC-01

Identifier Type: -

Identifier Source: org_study_id