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

• ClinicalTrials.gov Identifier: NCT01962376
• Recruitment Status: Unknown
• First Posted: October 14, 2013
• Last Update Posted: October 14, 2013
• Sponsor: Hebei Medical University
• Information provided by (Responsible Party): Yan Zhang, Hebei Medical University

Tracking Information

• First Submitted Date: October 8, 2013
• First Posted Date: October 14, 2013
• Last Update Posted Date: October 14, 2013
• Study Start Date: February 2013
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 10, 2013): progression-free survival(PFS) [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: October 10, 2013): Objective response rate (ORR) [ Time Frame: within 3 weeks after surgery ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 10, 2013)

• R0-resection rate [ Time Frame: within 3 weeks after surgery ]
• Overall survival (OS) [ Time Frame: 2 years ]
• Adverse events [ Time Frame: 2 years ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Gastric Cancer
• Liver Metastasis

Intervention

• Drug: Oxaliplatin;Capecitabine
  A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
  Other Name: Oxaliplatin plus capecitabine other names:XELOX.
• 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.
  Other Name: Capecitabine Plus Oxaliplatin Other names XELOX.

Study Arms

• Active Comparator: Bevacizumab,postoperative chemotherapy

  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

  Interventions:

  • Drug: Oxaliplatin;Capecitabine
  • Drug: Oxaliplatin;Capecitabine;Bevacizumab
• Experimental: Preoperative Chemotherapy

  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

  Interventions:

  • Drug: Oxaliplatin;Capecitabine
  • Drug: Oxaliplatin;Capecitabine;Bevacizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 10, 2013): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2015
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01962376
• Other Study ID Numbers: YZHANG0001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yan Zhang, Hebei Medical University
• Study Sponsor: Hebei Medical University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yan Zhang, Doctor; Hebei Medical University

• PRS Account: Hebei Medical University
• Verification Date: October 2013