Metastatic Colorectal CancerNCT01533740
Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients
An observational study of Metastatic Colorectal Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- fluorouracil/irinotecan/levo-folinic acid/bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital setting, single-center study, metastatic colorectal cancer patients treated with standard first line chemotherapy
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- fluorouracil/irinotecan/levo-folinic acid/bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracil/irinotecan/levo-folinic acid/bevacizumabDrug
Also called avastin (bevacizumab), campto (irinotecan)
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Tregs frequency on overall survival
Measured: 12 months
Secondary outcomes (2)
Impact of Tregs frequency progression free survival
Measured: 12 months
Impact of Tregs frequency radiologic response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Formica, University of Rome Tor Vergata
- Investigators
- Vincenzo Formica, MD, PhD, Principal investigator, 'Tor Vergata' University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533740
- Sponsor's protocol ID
- ONCOPTV-01-2012
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2012
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Formica V, Cereda V, di Bari MG, Grenga I, Tesauro M, Raffaele P, Ferroni P, Guadagni F, Roselli M. Peripheral CD45RO, PD-1, and TLR4 expression in metastatic colorectal cancer patients treated with bevacizumab, fluorouracil, and irinotecan (FOLFIRI-B). Med Oncol. 2013 Dec;30(4):743. doi: 10.1007/s12032-013-0743-0. Epub 2013 Oct 11.
PubMed 24114613
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01533740
- Acronym / sponsor ID
- ONCOPTV-01-2012
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital setting, single-center study, metastatic colorectal cancer patients treated with standard first line chemotherapy
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorouracil/irinotecan/levo-folinic acid/bevacizumabAlso: avastin (bevacizumab), campto (irinotecan)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 | Drug | – |
Primary outcome
Impact of Tregs frequency on overall survival
Time frame: 12 months
2 secondary outcomes
Impact of Tregs frequency progression free survival
Time frame: 12 months
Impact of Tregs frequency radiologic response rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Derived from this study: PubMed 24114613Formica V, Cereda V, di Bari MG, Grenga I, Tesauro M, Raffaele P, Ferroni P, Guadagni F, Roselli M. Peripheral CD45RO, PD-1, and TLR4 expression in metastatic colorectal cancer patients treated with bevacizumab, fluorouracil, and irinotecan (FOLFIRI-B). Med Oncol. 2013 Dec;30(4):743. doi: 10.1007/s12032-013-0743-0. Epub 2013 Oct 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Formica, MD, PhD principal investigator
'Tor Vergata' University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Tregs frequency on overall survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.