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Trial Title:
Preoperative Chemotherapy With Bevacizumab For Potentially Resectable Gastric Cancer With Liver Metastasis
NCT ID:
NCT01962376
Condition:
Gastric Cancer
Liver Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Stomach Neoplasms
Liver Neoplasms
Bevacizumab
Capecitabine
Oxaliplatin
Conditions: Keywords:
Capecitabine
Oxaliplatin
Bevacizumab
Potentially Resectable Gastric Cancer Liver Metastasis
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxaliplatin;Capecitabine
Description:
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for
every two cycles.
Arm group label:
Bevacizumab,postoperative chemotherapy
Arm group label:
Preoperative Chemotherapy
Other name:
Oxaliplatin plus capecitabine other names:XELOX.
Intervention type:
Drug
Intervention name:
Oxaliplatin;Capecitabine;Bevacizumab
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.
Arm group label:
Bevacizumab,postoperative chemotherapy
Arm group label:
Preoperative Chemotherapy
Other name:
Capecitabine Plus Oxaliplatin Other names XELOX.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Internal Medicine-Oncology
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Zhang, Doctor
Phone:
+8613315978336
Email:
13315978336@163.com
Investigator:
Last name:
Yan Zhang, Doctor
Email:
Principal Investigator
Start date:
February 2013
Completion date:
April 2015
Lead sponsor:
Agency:
Hebei Medical University
Agency class:
Other
Source:
Hebei Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01962376
