Status:
COMPLETED
Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination With 5-Fluorouracil (5FU) /or in FOLFIRI Regimen
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Gastrointestinal Cancer
CALCIUM LEVOFOLINATO (Ca-lev)
Eligibility:
All Genders
18+ years
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 ...
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 clinica...
Eligibility Criteria
Inclusion
- 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:
- 1\. Patients with known hypersensitivity to 5-FU or folinic acid , or to any of the excipients
Exclusion
Key Trial Info
Start Date :
November 3 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04680104
Start Date
November 3 2015
End Date
August 6 2019
Last Update
December 22 2020
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