About this trial
The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically proven rectal adenocarcinoma
no distant metastases on CT scan (M0 disease)
T4 tumor (cT4)
N2 disease (cN2)
Disqualifiers
absolute contraindications for MR imaging
distant metastases cannot be reliably excluded
synchronous cancer
chronic inflammatory bowel disease
Trial design
Factorial
Treatments tested in this trial
consolidation chemotherapy
Other intervention6 cycles CAPOX after chemoradiotherapy
induction chemotherapy
Other intervention4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy
Treatment groups
Trial outcomes
Primary outcomes
complete remission rate
The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.
Secondary outcomes
Overall survival
time from randomization to death
Survival without recurrence of the disease
time from the end of treatment (in the case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.
Disease free survival
the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes
local control
the time from the end of the treatment (in the case of cCR) or surgery to local recurrence
Sponsors and contacts
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