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Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

Primary Purpose

Liver Metastasis Colon Cancer

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
oxaliplatin
FOLFIRI Protocol
Bevacizumab
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastasis Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Subject Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
  • The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
  • A patient may have had prior chemotherapy or be previously untreated.
  • ECOG PS <2

Subject Exclusion Criteria:

  • Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
  • Patient may not have received prior treatment with hepatic artery infusion (HAI).
  • Extrahepatic metastases
  • Female patients who are pregnant or lactating

Sites / Locations

  • Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm prospective trial

Arm Description

Outcomes

Primary Outcome Measures

conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2019
Last Updated
October 16, 2020
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04003792
Brief Title
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Official Title
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm prospective trial
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
intra-arterial oxaliplatin administration
Intervention Type
Drug
Intervention Name(s)
FOLFIRI Protocol
Intervention Description
systemic FOLFIRI chemotherapy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
systemic bevacuzimab therapy
Primary Outcome Measure Information:
Title
conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma metastatic to the liver. The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. A patient may have had prior chemotherapy or be previously untreated. ECOG PS <2 Subject Exclusion Criteria: Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver. Patient may not have received prior treatment with hepatic artery infusion (HAI). Extrahepatic metastases Female patients who are pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Sadot, MD
Phone
+972-3-9376201
Email
eransadot@gmail.com
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Sadot
Email
eransadot@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

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