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

Primary Purpose

Gastric Cancer, Liver Metastasis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin;Capecitabine
Oxaliplatin;Capecitabine;Bevacizumab
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Capecitabine, Oxaliplatin, Bevacizumab, Potentially Resectable Gastric Cancer Liver Metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Internal Medicine-OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bevacizumab,postoperative chemotherapy

Preoperative Chemotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

progression-free survival(PFS)

Secondary Outcome Measures

Objective response rate (ORR)

Full Information

First Posted
October 8, 2013
Last Updated
October 10, 2013
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01962376
Brief Title
Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Liver Metastasis
Keywords
Capecitabine, Oxaliplatin, Bevacizumab, Potentially Resectable Gastric Cancer Liver Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab,postoperative chemotherapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Preoperative Chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin;Capecitabine
Other Intervention Name(s)
Oxaliplatin plus capecitabine other names:XELOX.
Intervention Description
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin;Capecitabine;Bevacizumab
Other Intervention Name(s)
Capecitabine Plus Oxaliplatin Other names XELOX.
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival(PFS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
within 3 weeks after surgery
Other Pre-specified Outcome Measures:
Title
R0-resection rate
Time Frame
within 3 weeks after surgery
Title
Overall survival (OS)
Time Frame
2 years
Title
Adverse events
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, Doctor
Organizational Affiliation
Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine-Oncology
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, Doctor
Phone
+8613315978336
Email
13315978336@163.com
First Name & Middle Initial & Last Name & Degree
Yan Zhang, Doctor

12. IPD Sharing Statement

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

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