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Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis

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ClinicalTrials.gov Identifier: NCT01962376
Recruitment Status : Unknown
Verified October 2013 by Yan Zhang, Hebei Medical University.
Recruitment status was:  Recruiting
First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Information provided by (Responsible Party):
Yan Zhang, Hebei Medical University

Tracking Information
First Submitted Date  ICMJE October 8, 2013
First Posted Date  ICMJE October 14, 2013
Last Update Posted Date October 14, 2013
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
progression-free survival(PFS) [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
Objective response rate (ORR) [ Time Frame: within 3 weeks after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2013)
  • R0-resection rate [ Time Frame: within 3 weeks after surgery ]
  • Overall survival (OS) [ Time Frame: 2 years ]
  • Adverse events [ Time Frame: 2 years ]
    Side effects during observation] Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis
Official Title  ICMJE Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis
Brief Summary The investigators assessed whether the addition of a preoperative regimen of Bevacizumab regimen to improves R0 resection rate and survival among patients with potentially resectable gastric cancer with liver metastasis.
Detailed Description

Groups 1:Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis.

Groups 2:Capecitabine Plus Oxaliplatin With placebo in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis.

Group 1 compare with Group 2 in disease-free survival time. Stage I:Preoperative therapy Capecitabine Plus Oxaliplatin With Bevacizumab is superior to Capecitabine Plus Oxaliplatin alines.

Stage II: therapy after surgery Capecitabine Plus Oxaliplatin With Bevacizumab is superior to Capecitabine Plus Oxaliplatin alones after surgery for over 6 months in all.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Liver Metastasis
Intervention  ICMJE
  • Drug: Oxaliplatin;Capecitabine
    A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
    Other Name: Oxaliplatin plus capecitabine other names:XELOX.
  • Drug: Oxaliplatin;Capecitabine;Bevacizumab
    A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.
    Other Name: Capecitabine Plus Oxaliplatin Other names XELOX.
Study Arms  ICMJE
  • Active Comparator: Bevacizumab,postoperative chemotherapy

    Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.

    Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.

    placebo:Physiological saline

    Interventions:
    • Drug: Oxaliplatin;Capecitabine
    • Drug: Oxaliplatin;Capecitabine;Bevacizumab
  • Experimental: Preoperative Chemotherapy

    Groups 1 drug: Oxaliplatin;Capecitabine;Bevacizumab A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.

    Groups 2 drug: Oxaliplatin;Capecitabine A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.placebo:Physiological saline

    Interventions:
    • Drug: Oxaliplatin;Capecitabine
    • Drug: Oxaliplatin;Capecitabine;Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1.Pathological tissue were gastric cancer by gastric and liver biopsy.

    2.Immunohistochemistry confirmed HER-2 ( - ).

    3.The number of liver metastasis is less than 3 and evey one is less than 5 cm.

    4.Liver metastasis must be clinically limited to Type H1 or Type H2.

    5.gastric cancer were able to resectable lesions or T1-4a N1-2 M0.

    6.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.

    7.Karnofsky performance status performance status >70.

    8.Inadequate hematopoietic function: Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3

    9.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN);alanine transaminase / Aspertate aminotransferase≤2.5 upper limit of normal range (ULN) (≤5.0 x ULN if hepatic metastasis); serum creatinine≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.

    10.expectancy must be more than 3 months.

    11.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.

    12.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.

Type H1: only one leaf with liver metastasis. Type H2: two leaves with a few scattered metastatic in liver.

Exclusion Criteria:

  • 1. Patients with other extrahepatic metastasis Include peritoneal metastasis.

    2. Primary was ulcerative type or the existence of the perforation.

    3. Patients with other malignancy in 5 years.

    4. Patients with severe liver disease, kidney disease, respiratory disease , uncontrolled diabetes or severe infections.

    5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, thromboembolisms, heart failure, clinical symptoms of heart disease.

    6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.

    7.Patients have history of organ transplantation.

    8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.

    9.Patients combined antitumor drug outside the research program.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01962376
Other Study ID Numbers  ICMJE YZHANG0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yan Zhang, Hebei Medical University
Study Sponsor  ICMJE Hebei Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yan Zhang, Doctor Hebei Medical University
PRS Account Hebei Medical University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP