230
Participants
Start Date
February 7, 2024
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2033
Short course radiotherapy
Patients will receive 5 daily fractions of radiotherapy. Each fraction will consist of 5 Gy for a total dose of 25 Gy.
Adjuvant chemotherapy (optional)
The choice of the adjuvant chemotherapy is to the investigator's discretion.
Total mesorectal excision
"Surgery must be performed according to the principles of total mesorectal excision. A watch \& wait approach is allowed for those subjects who have clinical complete response according to the local assessment."
Total neoadjuvant therapy
"The choice of the TNT is left to the investigator's discretion.~If RAPIDO:~* SCRT (5 fractions of 5 Gy), followed by~* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)~If RAPIDO light:~* SCRT (5 fractions of 5 Gy), followed by~* Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)~If OPRA with induction chemotherapy:~* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by~* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine)~If OPRA with consolidation chemotherapy:~* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by~* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX)"
RECRUITING
CHU Saint-Pierre, Brussels
RECRUITING
CHU Brugmann, Brussels
RECRUITING
Institut Jules Bordet, Anderlecht
RECRUITING
Chirec Delta, Auderghem
RECRUITING
AZ Turnhout, Turnhout
RECRUITING
ZAS Antwerpen, Antwerp
RECRUITING
UZA Antwerpen, Edegem
RECRUITING
CHU de Liège - Sart Tilman, Liège
NOT_YET_RECRUITING
CHR Sambre et Meuse (site Meuse), Namur
RECRUITING
CHU St Elisabeth, Namur
RECRUITING
CHU UCL Namur, Godinne
SUSPENDED
Grand Hôpital De Charleroi, Charleroi
NOT_YET_RECRUITING
CHU Charleroi, Charleroi
RECRUITING
CHA Libramont, Libramont
NOT_YET_RECRUITING
CHU Ambroise Pare, Mons
RECRUITING
Hôpital de Jolimont, Haine-Saint-Paul
RECRUITING
Epicura, Hornu
RECRUITING
UZ Gent, Ghent
RECRUITING
AZ Nikolaas, Sint-Niklaas
Lead Sponsor
Jules Bordet Institute
OTHER