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

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04680104

IRST159.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 2 patient groups

Cohort A

Description:

Infusion of Na-Lev plus 5-FU (unique administration by one 48h-infusional pump)

Cohort B

Description:

Infusion of Ca-Lev followed by infusion of 5-FU (two separated administrations by using one plastic bag followed by one 48h-infusional pump)