Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

February 1, 2014 updated by: Vincenzo Formica, University of Rome Tor Vergata

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00133
        • 'Tor Vergata' University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital setting, single-center study, metastatic colorectal cancer patients treated with standard first line chemotherapy

Description

Inclusion Criteria:

  • patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer not amenable to surgery
  • Adjuvant treatment ended ≥6 months before the study entry
  • No prior exposure to irinotecan and/or bevacizumab in the adjuvant treatment
  • No prior exposure to cytotoxic drugs for the metastatic disease
  • At least one measurable lesion according to the RECIST criteria
  • adequate laboratory parameters (Hemoglobin level ≥ 9.0 g/dL; Neutrophil count > 1.5 x 109/L; Platelets count >100 x 109/L; Total bilirubin <1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and/or ALAT (SGPT) <2.5 x UNL, or <5 x UNL in case of liver metastases; alkaline phosphatase <2.5 x UNL, or <5 x UNL in case of liver metastases; PT-INR/PTT < 1.5 x UNL;Creatinine clearance > 50 mL/min or serum creatinine <1.5 x UNL; Urine dipstick of proteinuria < 2+)
  • Written informed consent.
  • Patients must be accessible for treatment and follow up.

Exclusion Criteria:

  • Untreated brain metastases or spinal cord compression
  • History of inflammatory bowel disease and/or acute or subacute bowel occlusion.
  • Serious, non-healing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy.
  • Uncontrolled hypertension.
  • Clinically significant cardiovascular disease(cerebrovascular accidents ≤ 6 months, myocardial infarction ≤ 6 months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication)
  • Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.
  • Chronic, daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
  • Treatment with any investigational drug within 30 days prior to enrolment.
  • Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
  • Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline
  • Substance abuse, medical, psychological or social conditions that may interfere with the participation into the study or the evaluation of study results
  • Patients unable to swallow oral medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of Tregs frequency on overall survival
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of Tregs frequency progression free survival
Time Frame: 12 months
12 months
Impact of Tregs frequency radiologic response rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Investigators

  • Principal Investigator: Vincenzo Formica, MD, PhD, 'Tor Vergata' University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 10, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 1, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCOPTV-01-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on fluorouracil/irinotecan/levo-folinic acid/bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe