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

October 10, 2013 updated by: Yan Zhang, Hebei Medical University

Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Bevacizumab in Patients With Potentially Resectable Gastric Cancer With Liver Metastasis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • Department of Internal Medicine-Oncology
        • Contact:
        • Principal Investigator:
          • Yan Zhang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Capecitabine Plus Oxaliplatin Other names XELOX.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival(PFS)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: within 3 weeks after surgery
within 3 weeks after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years
2 years
R0-resection rate
Time Frame: within 3 weeks after surgery
within 3 weeks after surgery
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University

Investigators

  • Principal Investigator: Yan Zhang, Doctor, Hebei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZHANG0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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