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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Liver Metastasis Drug: Oxaliplatin;Capecitabine Drug: Oxaliplatin;Capecitabine;Bevacizumab Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis
Study Start Date : February 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
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

 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.
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

 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.


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival(PFS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: within 3 weeks after surgery ]

Other Outcome Measures:
  1. R0-resection rate [ Time Frame: within 3 weeks after surgery ]
  2. Overall survival (OS) [ Time Frame: 2 years ]
  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962376


Locations
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China, Hebei
Department of Internal Medicine-Oncology Recruiting
Shijiazhuang, Hebei, China, 050011
Contact: Yan Zhang, Doctor    +8613315978336    13315978336@163.com   
Principal Investigator: Yan Zhang, Doctor         
Sponsors and Collaborators
Hebei Medical University
Investigators
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Principal Investigator: Yan Zhang, Doctor Hebei Medical University
More Information
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Responsible Party: Yan Zhang, The first hospital of Shijiazhuang city, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01962376    
Other Study ID Numbers: YZHANG0001
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013
Keywords provided by Yan Zhang, Hebei Medical University:
Capecitabine
Oxaliplatin
Bevacizumab
Potentially Resectable Gastric Cancer Liver Metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Stomach Neoplasms
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Liver Diseases
 Bevacizumab
Capecitabine
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action