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

NCT ID: NCT04680104

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-03
• Study Completion Date: 2019-08-06

Brief Summary

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Passardi, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

References

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.

Reference Type: DERIVED

PMID: 33764600 (View on PubMed)

Other Identifiers

IRST159.01

Identifier Type: -

Identifier Source: org_study_id