Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5-Fluorouracil (5FU) /or in FOLFIRI Regimen

December 18, 2020 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5FU/or in FOLFIRI Regimen

Prospective observational study comparing calcium and sodium levofolinate in combination with 5FU/or in FOLFIRI regimen on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is an observational, perspective trial on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by gastrointestinal cancer requiring treatment according to FOLFIRI schedule

Description

Inclusion Criteria:

  1. Patients affected by gastrointestinal cancer including:

    • advanced colon-rectal cancer,
    • biliary tract cancer,
    • pancreatic carcinoma,
    • advanced gastric or gastro-esophageal junction adenocarcinoma requiring treatment according to folfiri schedule
  2. Participant is willing and able to give informed consent for participation in the study.
  3. Male or Female aged >18 years.
  4. Life expectancy > 3 months
  5. Performance Status (PS) 0-1

Exclusion criteria:

1. Patients with known hypersensitivity to 5-FU or folinic acid , or to any of the excipients

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort A
Infusion of Na-Lev plus 5-FU (unique administration by one 48h-infusional pump)
Cohort B
Infusion of Ca-Lev followed by infusion of 5-FU (two separated administrations by using one plastic bag followed by one 48h-infusional pump)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 2 years
Safety profiles of Na-Lev and Ca-Lev when administered in combination with 5-FU in FOLFIRI regimen to cancer patients under standard clinical practice. Reported Adverse Events (AE) will be summarized by system organ class, seriousness, severity (according to NCI -Common Terminology Criteria for Adverse Events, CTCAE version 4.0) and relationship to study drug. Comparison between groups will be performed using non parametric statistical test.
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
organizational impact on Drug production
Time Frame: up to 2 years
organizational impact that the introduction of Na-Lev would have on Drug production and delivery. The set-up times of preparation of Na-lev (by manual procedure) with respect to Ca-lev will be measured: for each individual therapy prescribed by clinicians the timing of the manual preparation in Official Pharmaceutical Lab (LFO) will be measured by chronometer, for the entire duration of each production line.
up to 2 years
economical impact
Time Frame: up to 2 years
economical impact hat the introduction of Na-Lev would have on Drug production and delivery. The set-up times of preparation of Na-lev (by manual procedure) with respect to Ca-lev will be measured: after preparation, the difference in waste of residual drug will be measured (if present) for each production. Quantity of residual drugs will be reported for each product line taking account of weight of enrolled patients.
up to 2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alessandro Passardi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRST159.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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