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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-03

Study Completion Date

2019-08-06

Brief Summary

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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

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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

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

Keywords

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Levofolinic Acid Gastrointestinal Cancer FOLFIRI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro Passardi, MD

Role: PRINCIPAL_INVESTIGATOR

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

References

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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

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IRST159.01

Identifier Type: -

Identifier Source: org_study_id