NCT01533740

Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

Observational Study of the Impact of Circulating T Regulatory Cells (Tregs) on Clinical Outcome of Metastatic Colorectal Cancer (MCRC) Patients Treated With Standard Fluorouracil/Irinotecan/Bevacizumab First Line Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil/irinotecan/levo-folinic acid/bevacizumab	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

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-02-15
• Last updated: 2014-02-04

Locations

1 site across 1 country: Italy