A national randomised multi-centre trial to assess the effect of oral magnesium supplementation on the kinetics of magnesium wasting induced by EGFR targeted antibody therapy for colorectal carcinoma (the MAGNET trial)...
|Type of cancer||Colorectal carcinoma|
Randomised, parallel group multi-centre study; Arms; No crossover group; Placebo controlled;
|Inclusion Main criteria||
Subjects with colorectal cancer in whom treatment with anti-EGFR targeted antibodies is being started.
Male or female subjects aged between 18 and 80 years
|Exclusion Main criteria||
Randomisation will be performed centrally using a set of consecutively numbered sealed envelopes containing the treatment arm code according to a predetermined, computer generated random table. The study medication will be provided at each investigational site. Upon randomisation of part 1, patients will either receive no medication or 28 sachets of magnesium gluconate 3g every two weeks. Stratification for combination therapy with oxaliplatin will be performed. In part 2, patients will be provided with 28 or 84 sachets of magnesium gluconate 3 every two weeks. If anti-EGFR treatment has to be postponed, for any reason, patients will be asked to continue their study drug at the same dosage.
Date of beginning of study: (First patient in). Last patient in. Date of end of study: (Last patient out).
Sabine Tejpar; Hubert Piessevaux;
UZ Leuven - S. Tejpar Algemene Kliniek St.-Jan - Brussel - Dr. P. Van Maele AZ Damiaan - Oostende - Dr. G. Deboever AZ KLINA - Brasschaat - Dr. W. Demey AZ Maria Middelares - Gent - Dr. E. Monsaert AZ Sint Jozef - Malle - Dr. W. Demey AZ Sint Maarten - Mechelen - Dr. M. Ferrante AZ St Jan AV - Brugge - Dr. A. Bols AZ St-Jan - Brugge - Dr. J. Arts C.H.U. Sart-Tilman - Liège - Dr. M. Polus CHPLT - Verviers - Dr. Hassan Kalantari Cliniques Universitaires Saint Luc - Brussels - Prof. Y Humblet H.-Hartziekenhuis vzw Roeselare-Menen - Dr. G. Ghillebert Sint Augustinusziekenhuis - Wilrijk - Dr. F. Van de Mierop Sint-Jozefkliniek Bornem-Willebroek - Bornem - Dr. T. Rondou St Elisabeth Ziekenhuis - Turnhout - Dr. J. Janssens ULB Erasme - Brussels - Dr. A. Demols UMT site RHMS/CHWAPI Tournai - Dr. K. Kargar Samani UZ Antwerpen - Prof. M. Peeters UZ Gent - Dr. S. Laurent
|Protocol summary||Link to ClinicalTrials.gov|
|Interest to firstname.lastname@example.org|