The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments. Another objective of the trial is to assess and compare the safety of each treatment.
Further study details as provided by Centre Oscar Lambret.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
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 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days.
Centre Paul Papin
Angers, France
Centre Hospitalier
Armentières, France
Centre Hospitalier de Béthune
Beuvry, France
patients preference after randomization and cross-over
Time frame: after 2 cycles of treatment
safety of each treatment
Time frame: at day 56 (after two cycles of treatment)
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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
...and 3 more locations