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Trial record 67 of 998 for:    colon cancer AND resection

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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ClinicalTrials.gov Identifier: NCT04003792
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eran Sadot, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Liver Metastasis Colon Cancer Drug: oxaliplatin Drug: FOLFIRI Protocol Drug: Bevacizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin


Intervention Details:
  • Drug: oxaliplatin
    intra-arterial oxaliplatin administration
  • Drug: FOLFIRI Protocol
    systemic FOLFIRI chemotherapy
  • Drug: Bevacizumab
    systemic bevacuzimab therapy


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003792


Contacts
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Contact: Eran Sadot, MD +972-3-9376201 eransadot@gmail.com

Sponsors and Collaborators
Rabin Medical Center

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Responsible Party: Eran Sadot, Head of Hepatopancreatobiliary service, Principal Investigator, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04003792     History of Changes
Other Study ID Numbers: 0275-19-RMC
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Liver Diseases
Bevacizumab
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors