Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis
NCT ID: NCT02399410
Last Updated: 2024-01-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-11-04
Study Completion Date
2023-11-09
Brief Summary
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The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.
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Detailed Description
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Conditions
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Colorectal Neoplasms
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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bevacizumab and CRS with oxaliplatin
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Group Type
EXPERIMENTAL
perioperative chemotherapy plus bevacizumab
Intervention Type
DRUG
preoperative and postoperative combination chemotherapy with bevacizumab
cytoreductive surgery
Intervention Type
PROCEDURE
complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.
Intraperitoneal Oxaliplatin
Intervention Type
DRUG
Pump-driven intraperitoneal administration of oxaliplatin
Interventions
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perioperative chemotherapy plus bevacizumab
preoperative and postoperative combination chemotherapy with bevacizumab
Intervention Type
DRUG
cytoreductive surgery
complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.
Intervention Type
PROCEDURE
Intraperitoneal Oxaliplatin
Pump-driven intraperitoneal administration of oxaliplatin
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
* absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
* resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
* complete macroscopic cytoreduction at the time of surgery (CC-0/1)
* good general health status (Karnofsky index \> 70%)
* expected life expectancy more than 6 months
* no other malignancy than disease under study
* serum creatinine \< 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
* serum total bilirubin \< 1.5 mg/dl
* platelet count \> 100,000/ml
* hemoglobin \> 9g/dl
* neutrophil granulocytes \> 1,500/ml
* International Normalized Ration (INR) 2 or \< 2
* Absence of alcohol and/or drug abuse
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Absence of heart failure (NYHA 2 or \> 2) or significant coronary artery disease
* No pregnancy or breast feeding
* Adequate contraception in fertile patients
* absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
* resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
* complete macroscopic cytoreduction at the time of surgery (CC-0/1)
* good general health status (Karnofsky index \> 70%)
* expected life expectancy more than 6 months
* no other malignancy than disease under study
* serum creatinine \< 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
* serum total bilirubin \< 1.5 mg/dl
* platelet count \> 100,000/ml
* hemoglobin \> 9g/dl
* neutrophil granulocytes \> 1,500/ml
* International Normalized Ration (INR) 2 or \< 2
* Absence of alcohol and/or drug abuse
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Absence of heart failure (NYHA 2 or \> 2) or significant coronary artery disease
* No pregnancy or breast feeding
* Adequate contraception in fertile patients
Exclusion Criteria
* No written informed consent
* tumour in the presence of obstruction
* evidence of extra-abdominal disease or extensive liver metastasis
* peritoneal cancer index \> 25
* active bacterial, viral or fungal infection
* active gastro-duodenal ulcer
* parenchymal liver disease (any stage cirrhosis)
* uncontrolled diabetes mellitus
* severe obstructive or restrictive respiratory insufficiency
* psychiatric pathology capable of affecting comprehension and judgment faculty
* Known allergy to oxaliplatin
* tumour in the presence of obstruction
* evidence of extra-abdominal disease or extensive liver metastasis
* peritoneal cancer index \> 25
* active bacterial, viral or fungal infection
* active gastro-duodenal ulcer
* parenchymal liver disease (any stage cirrhosis)
* uncontrolled diabetes mellitus
* severe obstructive or restrictive respiratory insufficiency
* psychiatric pathology capable of affecting comprehension and judgment faculty
* Known allergy to oxaliplatin
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Ghent
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Wim P Ceelen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Site Status
Countries
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Belgium
References
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BACKGROUND
Ceelen W, Van Nieuwenhove Y, Putte DV, Pattyn P. Neoadjuvant chemotherapy with bevacizumab may improve outcome after cytoreduction and hyperthermic intraperitoneal chemoperfusion (HIPEC) for colorectal carcinomatosis. Ann Surg Oncol. 2014 Sep;21(9):3023-8. doi: 10.1245/s10434-014-3713-7. Epub 2014 Apr 23.
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RESULT
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RESULT
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RESULT
Olsen MW, Ley CD, Junker N, Hansen AJ, Lund EL, Kristjansen PE. Angiopoietin-4 inhibits angiogenesis and reduces interstitial fluid pressure. Neoplasia. 2006 May;8(5):364-72. doi: 10.1593/neo.06127.
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RESULT
Nakahara T, Norberg SM, Shalinsky DR, Hu-Lowe DD, McDonald DM. Effect of inhibition of vascular endothelial growth factor signaling on distribution of extravasated antibodies in tumors. Cancer Res. 2006 Feb 1;66(3):1434-45. doi: 10.1158/0008-5472.CAN-05-0923.
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RESULT
Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. doi: 10.1038/nm988. Epub 2004 Jan 25.
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RESULT
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Reference Type
RESULT
Willaert W, Van Der Speeten K, Liberale G, Ceelen W. BEV-IP: Perioperative chemotherapy with bevacizumab in patients undergoing cytoreduction and intraperitoneal chemoperfusion for colorectal carcinomatosis. BMC Cancer. 2015 Dec 16;15:980. doi: 10.1186/s12885-015-1954-x.
Reference Type
DERIVED
Other Identifiers
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EC/2014/1042
Identifier Type: -
Identifier Source: org_study_id
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