NCT01929616|CompletedPhase 2DMC
Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)
RegARd-C
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Sponsor study identifier
interventional
141
1 country
17
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 13, 2016
Actual (reported)Study Completion
June 17, 2019
Actual (reported)The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 17, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2013
Actual (reported)August 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 28, 2013
Actual (reported)May 13, 2016
Actual (reported)June 17, 2019
Actual (reported)Overall survival (OS)
2 years from first patient in
Occurence of Adverse events
Every 28 days till 28 days after stopping therapy. An average of 2 months is expected.
Evaluation of tumour response
Every 2 months till progression of the disease. An average of 2 months is expected.
Metabolic response assessed by FDG PET
2 FDGPET will be perfomed : at Baseline (day 0) and at D14
Molecular aberrations
at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected.
A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks.
Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UZA
Antwerp, Edegem, 2650, Belgium
Jules Bordet Institute
Brussels, 1000, Belgium
Hopital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium
Grand Hopital de Charleroi
Charleroi, 6000, Belgium
UZ Ghent
Ghent, Belgium
AZ groeninge
Kortrijk, 8500, Belgium
Charette N, Vandeputte C, Ameye L, Bogaert CV, Krygier J, Guiot T, Deleporte A, Delaunoit T, Geboes K, Van Laethem JL, Peeters M, Demolin G, Holbrechts S, Flamen P, Paesmans M, Hendlisz A. Prognostic value of adipose tissue and muscle mass in advanced colorectal cancer: a post hoc analysis of two non-randomized phase II trials. BMC Cancer. 2019 Feb 12;19(1):134. doi: 10.1186/s12885-019-5319-8.
Hendlisz A, Deleporte A, Vandeputte C, Charette N, Paesmans M, Guiot T, Garcia C, Flamen P. Regorafenib assessment in refractory advanced colorectal cancer: RegARd-C study protocol. BMJ Open. 2015 Mar 9;5(3):e007189. doi: 10.1136/bmjopen-2014-007189.
Alain Hendlisz, MD
Jules Bordet Institute
141 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2013
First Posted
August 28, 2013
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Regorafenib in Frail and/or Unfit for Chemotherapy Patients With Metastatic Colorectal Cancer
Contact the study team to confirm eligibility.
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Clinique St Joseph
Liège, 4000, Belgium
Centre hospitalier de Jolimont
Lobbes, 6540, Belgium
CHU Ambroise Paré
Mons, 7000, Belgium
Centre Hospitalier Régional de Namur
Namur, 5000, Belgium
Clinique et Maternité Sainte Elisabeth
Namur, 5000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
Hartziekenhuis Roeselare-Menen (HHRM)
Roeselare, 8800, Belgium
AZ Turnhout
Turnhout, 2300, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, 5530, Belgium
Primary Completion
May 13, 2016
Actual (reported)Study Completion
June 17, 2019
Actual (reported)Last Updated
June 25, 2019
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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