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Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Primary Purpose

HER-2 Positive Gastric Cancer, Liver Metastasis

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

About this trial

This is an interventional treatment trial for HER-2 Positive Gastric Cancer focused on measuring XELOX, Herceptin, Potentially Resectable Gastric Cancer

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 (+)or FISH(+).

    3.gastric cancer with liver metastasis were not able to resectable lesions.

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

    5.ECOG performance status 0-1.

    6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN); ALT / AST≤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.

    8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.

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

    11.The operation can complete the D2 operation(LNM≥15).

    12.LVEF≥50%

Exclusion Criteria:

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

    3. Patients with other malignancy in 5 years.

    4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.

    5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, 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 Type

Experimental

Arm Label

Herceptin

Arm Description

drug: Oxaliplatin;Capecitabine;Herceptin A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles. To explore the effect of herceptin with chemotherapy for potentially resectable HER-2 positive gastric cancer with liver metastasis

Outcomes

Primary Outcome Measures

progression-free survival(PFS)

Secondary Outcome Measures

Objective response rate (ORR)

Full Information

First Posted
October 8, 2013
Last Updated
March 4, 2015
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02380131
Brief Title
Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
Official Title
Phase IV Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Herceptin in Patients With Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (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
Stage I：preoperative therapy Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;
Detailed Description
The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER-2 Positive Gastric Cancer, Liver Metastasis
Keywords
XELOX, Herceptin, Potentially Resectable Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Herceptin
Arm Type
Experimental
Arm Description
drug: Oxaliplatin;Capecitabine;Herceptin A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles. To explore the effect of herceptin with chemotherapy for potentially resectable HER-2 positive gastric cancer with liver metastasis
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin plus Capecitabine
Other Intervention Name(s)
Oxaliplatin plus capecitabine other names:XELOX.
Intervention Description
A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.
Intervention Type
Drug
Intervention Name(s)
Herceptin
Other Intervention Name(s)
Trastuzumab
Intervention Description
Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 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
The number of Participants with adverse events
Description
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0.
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 (+)or FISH(+). 3.gastric cancer with liver metastasis were not able to resectable lesions. 4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis. 5.ECOG performance status 0-1. 6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN); ALT / AST≤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. 8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days. 10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later. 11.The operation can complete the D2 operation(LNM≥15). 12.LVEF≥50% Exclusion Criteria: 1. Patients with other extrahepatic metastasis Include peritoneal metastasis. 3. Patients with other malignancy in 5 years. 4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome. 5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, 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
Qun Zhao, 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
Qun Zhao, Doctor
Phone
+8613930162111
Email
zhaoqun516@126.com
First Name & Middle Initial & Last Name & Degree
Qun Zhao, Dortor

12. IPD Sharing Statement

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Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

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