Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
NCT ID: NCT00905047
Last Updated: 2012-07-23
Study Results
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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COMPLETED
PHASE3
89 participants
INTERVENTIONAL
2005-09-30
2011-09-30
Brief Summary
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Another objective of the trial is to assess and compare the safety of each treatment.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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XELODA
XELODA
XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days.
Cycle treatment duration : 21 days
UFT
TEGAFUR URACIL - FOLINIC ACID
Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.
Duration of treatment cycle : 35 days.
Interventions
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XELODA
XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days.
Cycle treatment duration : 21 days
TEGAFUR URACIL - FOLINIC ACID
Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days.
Duration of treatment cycle : 35 days.
Eligibility Criteria
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Inclusion Criteria
* Age \> or = 18 years old
* PS-WHO \< or = 2
* Polynuclear neutrophil leukocytes \> or = 1500/mm3, platelets \> or = 100000/mm3
* Total bilirubin \< or = 3 ULN, ASAT-ALAT \< or = 2.5 ULN
* Effective contraception
* Written informed consent signed
Exclusion Criteria
* Contraindication to fluoropyrimidines
* Treatment with sorivudine and its chemical analogs such as brivudine
* Severe hepatic insufficiency
* Severe renal insufficiency
* Pregnant or lactating woman
* Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
18 Years
ALL
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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ADENIS Antoine, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier
Armentières, , France
Centre Hospitalier de Béthune
Beuvry, , France
Centre Hospitalier de CHOLET
Cholet, , France
Centre Leonard de Vinci
Dechy, , France
Polyclinique du Bois
Lille, , France
Centre Oscar Lambret
Lille, , France
Hopital Saint Vincent de Paul
Lille, , France
Centre Hospitalier Regional
Lille, , France
Centre Hospitalier
Roubaix, , France
Centre Joliot-Curie
Saint Martin Les Boulogne, , France
Centre Hospitalier
Valenciennes, , France
Clinique des Dentellieres
Valenciennes, , France
Countries
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Other Identifiers
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COLOCROSS
Identifier Type: -
Identifier Source: org_study_id