364
Participants
Start Date
November 13, 2020
Primary Completion Date
March 1, 2024
Study Completion Date
March 1, 2030
Combination drug
"Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles.~If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI."
Chemoradiotherapy
"Concomitant chemotherapy agent: capecitabine~Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy."
Surgery locally recurrent rectal cancer
"Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon.~Intraoperative radiotherapy is optional."
NOT_YET_RECRUITING
UZ Gent, Ghent
RECRUITING
Amsterdam UMC, Amsterdam
RECRUITING
Antoni van Leeuwenhoek, Amsterdam
RECRUITING
University Medical Centre Groningen, Groningen
RECRUITING
Leids University Medical Centre, Leiden
RECRUITING
Haaglanden Medical Centre, Leidschendam
RECRUITING
Maastricht University Medical Centre, Maastricht
RECRUITING
Erasmus Medical Centre, Rotterdam
NOT_YET_RECRUITING
Oslo Universitetssykehus, Oslo
NOT_YET_RECRUITING
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon
NOT_YET_RECRUITING
Sahlgrenska Universitetssjukhuset, Gothenburg
NOT_YET_RECRUITING
Skåne Universitetssjukhuset, Malmo
NOT_YET_RECRUITING
Karolinska Universitetssjukhuset, Stockholm
RECRUITING
Catharina Hospital, Eindhoven
Catharina Ziekenhuis Eindhoven
OTHER