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Trial record 46 of 435 for:    colon cancer AND Capecitabine

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
Sponsor:
Information provided by (Responsible Party):
Filippo Pietrantonio, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
Capecitabine, oxaliplatin, irinotecan and bevacizumab as perioperative strategy of borderline and/or high risk resectable colorectal cancer liver metastases

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: open label
Single arm, open label
Drug: capecitabine, oxaliplatin, irinotecan and bevacizumab
perioperative COI-B




Primary Outcome Measures :
  1. Pathological response rate [ Time Frame: Assessed at the time of surgery of liver metastases (between weeks 17-20 from enrollment) ]

    Primary:

    - 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%).



Secondary Outcome Measures :
  1. RECIST Response rate [ Time Frame: Available at week 9 after enrollment ]
    - Response rate according to RECIST vers. 1.1 criteria



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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

Inclusion Criteria:

Inclusion criteria:

  • Histological diagnosis of colorectal adenocarcinoma.
  • Liver-limited metastases or metastases mainly (≥80% total disease burden) limited to the liver with extrahepatic disease judged resectable concomitantly or sequentially. Primary tumor may be resected or not, but patient must not be symptomatic for T.
  • Previous adjuvant therapy is allowed if it had been terminated for at least 6 months.
  • Previous first line treatment (irinotecan or oxaliplatin containing regimen) with stable or partial response after no more than 3 months of treatment
  • Age >= 18 years
  • Performance Status (ECOG <2)
  • Adequate organ function including the following:
  • Adequate bone marrow reserve: WBC count >3.0x109/L, absolute neutrophil count >1.5x109/L, platelet count >100x109/L, and hemoglobin >10 g/dL .
  • Hepatic: bilirubin < 1.5 times the ULN, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 xULN
  • Renal : serum creatinin <2.0xULN
  • Patients compliance and geographic proximity that allows for adequate follow-up
  • Patients must sign an informed consent document (ICD)
  • Male and female patients with reproductive potential must use an approved contraceptive method.

Exclusion Criteria:

  • Tumor involvement of liver > 75%
  • Chance of a liver remnant after surgery < 25%
  • Eligibility for concurrent radiotherapeutic treatment
  • Disease progression during first line chemotherapy with FOLFOX, XELOX, FOLFIRI or XELIRI plus bevacizumab
  • Previous treatment with more than 3 months of FOLFOX or FOLFIRI
  • Previous therapy with bevacizumab or cetuximab or panitumumab
  • Administration of other experimental drugs during the study.
  • Body Mass Index > 35
  • Brain metastases.
  • Pregnancy and breast-feeding.
  • Serious or uncontrolled medical pathologies or active infections that would jeopardize the possibility of receiving the investigated treatment. Disorders that could influence the absorption of capecitabine (e.g. malabsorption), intestinal occlusion, Crohn's disease or ulcerative colitis.
  • Psychiatric disorders, neurologic disease or other conditions that would make it impossible to comply with the protocol procedures. Peripheral neuropathy not related to oxaliplatin previous administration.
  • Previous dangerous life threatening toxicities from fluoropyrimidine.
  • Positive anamnesis with regard to other neoplastic diseases except for the ones that have been cured for more than 5 years.

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): NCT02086656


Locations
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Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Mi, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Filippo de Braud, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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Responsible Party: Filippo Pietrantonio, M.D., MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02086656     History of Changes
Other Study ID Numbers: COI-B
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Keywords provided by Filippo Pietrantonio, M.D., Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
liver metastases
colorectal cancer
perioperative treatment
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Bevacizumab
Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites