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.

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.

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