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NCT Number: NCT04680104

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 on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed FOLFIRI in standard clinical practice.

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Key information

Conditions

Gastrointestinal Cancer CALCIUM LEVOFOLINATO (Ca-lev) Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site SODIUM LEVOFOLINATO (Na-lev)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female aged >18 years.
  • Life expectancy > 3 months
  • Performance Status (PS) 0-1

Exclusion criteria

  • Patients with known hypersensitivity to 5-FU or folinic acid , or to any of the excipients

Treatment and study plan

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to 2 years

    Safety profiles of Na-Lev and Ca-Lev when administered in combination with 5-FU in FOLFIRI regimen to cancer patients under standard clinical practice. Reported Adverse Events (AE) will be summarized by system organ class, seriousness, severity (according to NCI -Common Terminology Criteria for Adverse Events, CTCAE version 4.0) and relationship to study drug. Comparison between groups will be performed using non parametric statistical test.

Secondary outcomes

  1. organizational impact on Drug production

    Time frame: up to 2 years

    organizational impact that the introduction of Na-Lev would have on Drug production and delivery. The set-up times of preparation of Na-lev (by manual procedure) with respect to Ca-lev will be measured: for each individual therapy prescribed by clinicians the timing of the manual preparation in Official Pharmaceutical Lab (LFO) will be measured by chronometer, for the entire duration of each production line.

  2. economical impact

    Time frame: up to 2 years

    economical impact hat the introduction of Na-Lev would have on Drug production and delivery. The set-up times of preparation of Na-lev (by manual procedure) with respect to Ca-lev will be measured: after preparation, the difference in waste of residual drug will be measured (if present) for each production. Quantity of residual drugs will be reported for each product line taking account of weight of enrolled patients.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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