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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01962376
• Other study ID #: YZHANG0001
• Status: Recruiting
• Phase: Phase 4
• First received: October 8, 2013
• Last updated: October 10, 2013
• Start date: February 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2013
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin;Capecitabine
A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk?Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
• 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.

Locations

Country	Name	City	State
China	Department of Internal Medicine-Oncology	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	R0-resection rate		within 3 weeks after surgery	No
Other	Overall survival (OS)		2 years	No
Other	Adverse events	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	Yes
Primary	progression-free survival(PFS)		2 years	No
Secondary	Objective response rate (ORR)		within 3 weeks after surgery	No