Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

Sponsor
University of Rome Tor Vergata
Study ID
NCT01533740
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • fluorouracil/irinotecan/levo-folinic acid/bevacizumab — DRUG
    standard first line chemotherapy with: bevacizumab 5 mg/kg intravenous (i.v.) infusion on day 1; irinotecan 180 mg/m2 i.v. infusion on day 1, levo-folinic acid 200 mg/m2 i.v. infusion on day 1, 5-fluorouracil 400 mg/m2 i.v. bolus on day 1 and 2,400 mg/m2 i.v. infusion over 46 hours; infusions repeated every 2 weeks

Study Details

Aim of the present study is to investigate whether baseline or early post-treatment (one month after treatment commencement) frequency of peripheral T regulatory lymphocytes (Tregs OR CD4+/CD25high/FOXP3+ T cells), known to suppress antitumor immune response, may influence long-term clinical outcome (i.e. radiological response, progression-free survival or overall survival) in metastatic colorectal cancer patients treated with a standard first-line chemotherapy including fluorouracil, irinotecan and bevacizumab

Key Dates

Start date
Mar 31, 2012
Status verified
Feb 2014
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
31 participants (actual)

Primary Outcome Measure

Impact of Tregs frequency on overall survival [ Time Frame: 12 months ]

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