Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Peri-operative chemotherapy of ECX
Peri-operative chemotherapy of XP
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, Peri-operative 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.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
chemotherapy with ECX
chemotherapy with XP
Arm Description
chemotherapy with ECX
chemotherapy with XP
Outcomes
Primary Outcome Measures
the relapse-free survival time/rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01558947
Brief Title
Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, Peri-operative chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy with ECX
Arm Type
Experimental
Arm Description
chemotherapy with ECX
Arm Title
chemotherapy with XP
Arm Type
Experimental
Arm Description
chemotherapy with XP
Intervention Type
Drug
Intervention Name(s)
Peri-operative chemotherapy of ECX
Other Intervention Name(s)
ECX chemotherapy
Intervention Description
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
Intervention Name(s)
Peri-operative chemotherapy of XP
Other Intervention Name(s)
XP chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
the relapse-free survival time/rate
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiangdong Cheng, MD
Phone
+86 571 88122516
Email
abdsurg@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiangdong Cheng, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangdong Cheng, MD
Phone
+86 571 88122516
Email
abdsurg@hotmail.com
First Name & Middle Initial & Last Name & Degree
xiangdong Cheng, MD
12. IPD Sharing Statement
Learn more about this trial
Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer
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