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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: Peri-operative chemotherapy of ECX; Drug: Peri-operative chemotherapy of XP	Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
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
Study Start Date :	January 2011
Estimated Primary Completion Date :	December 2012
Estimated Study Completion Date :	June 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: chemotherapy with ECX; chemotherapy with ECX	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.; Other Name: ECX chemotherapy
Experimental: chemotherapy with XP; chemotherapy with XP	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.; Other Name: XP chemotherapy

Outcome Measures

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Primary Outcome Measures :

1. the relapse-free survival time/rate [ Time Frame: 3 years ]

Eligibility Criteria

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

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: xiangdong Cheng, MD	+86 571 88122516	abdsurg@hotmail.com

Locations

China, Zhejiang
Zhejiang Cancer Hospital	Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: xiangdong Cheng, MD +86 571 88122516 abdsurg@hotmail.com
Principal Investigator: xiangdong Cheng, MD

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

Principal Investigator:	xiangdong Cheng, MD	Zhejiang Cancer Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:	NCT01558947 History of Changes
Other Study ID Numbers:	PC-AGC-01
First Posted:	March 20, 2012
Last Update Posted:	March 20, 2012
Last Verified:	March 2012

Keywords provided by Zhejiang Cancer Hospital:

gastric cancer; Peri-operative chemotherapy

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Cisplatin; Capecitabine	Epirubicin; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors