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

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: Completed
• Conditions: Gastrointestinal Cancer; CALCIUM LEVOFOLINATO (Ca-lev); SODIUM LEVOFOLINATO (Na-lev)

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: Observational
• Enrollment (Actual): 64

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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

Outcome Measure	Measure Description	Time Frame
organizational impact on Drug production	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	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

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Investigators: Principal Investigator: Alessandro Passardi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Publications and helpful links

General Publications

• Passardi A, Monti M, Donati C, Foca F, Pagan F, Rapposelli I, Ruscelli S, Bartolini G, Valgiusti M, Matteucci L, Sullo F, Sbaffi S, Crudi L, Frassineti GL, Masini C. Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination with 5-Fluorouracil in the FOLFIRI Regimen. Oncologist. 2021 Aug;26(8):e1314-e1319. doi: 10.1002/onco.13762. Epub 2021 Apr 22.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2015
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Gastrointestinal Cancer; FOLFIRI; Levofolinic Acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID 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