PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES (COI-B)
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|ClinicalTrials.gov Identifier: NCT02086656|
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Liver Metastases||Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab||Phase 2|
Previous studies demonstrated a significant association between tumor regression grade of hepatic colorectal metastases (TRG1: complete pathological response; TRG2: major pathological response; TRG3: partial pathological response; versus TRG4-5 no pathological response) and outcome in terms of survival after neoadjuvant treatment. In particular, retrospective data showed an association between oxaliplatin-based chemotherapy and improvement of grade and percentage of tumor regression; moreover, the addition of Bevacizumab seems to improve TRG over chemotherapy alone, conferring also a protection against liver damage due to chemotherapy-induced sinusoidal obstruction syndrome.
This is the rationale that induced us to carry out an evaluation and feasibility assessment of a perioperative approach with COI-B regimen in patients affected by high risk or borderline resectable colorectal liver metastases, with or without previous resection of primary tumor.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PERIOPERATIVE TREATMENT WITH COI-B (CAPECITABINE, OXALIPLATIN, IRINOTECAN AND BEVACIZUMAB) OF HIGH RISK OR BORDERLINE RESECTABLE COLORECTAL CANCER LIVER METASTASES|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 30, 2017|
|Actual Study Completion Date :||March 30, 2017|
Experimental: open label
Single arm, open label
Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab
- Pathological response rate [ Time Frame: Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment) ]
- To evaluate the activity of the regimen with regards to major/complete pathological response. Major/complete pathological response is measured by pathologist in terms of tumor regression grade (TRG) as described by Rubbia-Brandt L, Annals of Oncology 2007 (percentage of vial residual cells 0-10%).
- RECIST Response rate [ Time Frame: Available at week 9 after enrollment ]- Response rate according to RECIST vers. 1.1 criteria
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): NCT02086656
|Fondazione IRCCS Istituto Nazionale Tumori|
|Milan, Mi, Italy, 20133|
|Principal Investigator:||Filippo de Braud, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|