Clinical trial NCT04680104: Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5-Fluorouracil (5FU) /or in FOLFIRI Regimen
Official title: Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5FU/or in FOLFIRI Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Cancer
CALCIUM LEVOFOLINATO (Ca-lev)
SODIUM LEVOFOLINATO (Na-lev)
Keywords: Levofolinic Acid
Gastrointestinal Cancer
FOLFIRI
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by gastrointestinal cancer requiring treatment according to FOLFIRI schedule

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.

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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to 2 years
Secondary outcomes:
measure: organizational impact on Drug production
timeFrame: up to 2 years
measure: economical impact
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
name: Alessandro Passardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.