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

Sponsor

Hebei Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02380131

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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;

Condition or Disease	Intervention/Treatment	Phase
HER-2 Positive Gastric Cancer Liver Metastasis	Drug: Oxaliplatin plus Capecitabine Drug: Herceptin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Herceptin 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	Drug: Oxaliplatin plus Capecitabine A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles. Other Names: Oxaliplatin plus capecitabine other names:XELOX. Drug: Herceptin 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. Other Names: Trastuzumab

Arm

Intervention/Treatment

Experimental: Herceptin

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

Drug: Oxaliplatin plus Capecitabine

A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.

Other Names:

Oxaliplatin plus capecitabine other names:XELOX.

Drug: Herceptin

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.

Other Names:

Trastuzumab

Outcome Measures

Primary Outcome Measures

progression-free survival(PFS) [2 years]

Secondary Outcome Measures

Objective response rate (ORR) [within 3 weeks after surgery]

Other Outcome Measures

R0-resection rate [within 3 weeks after surgery]
Overall survival (OS) [2 years]
The number of Participants with adverse events [2 years]
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Patients with other malignancy in 5 years.
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.