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
International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
6 cycles CAPOX after chemoradiotherapy
4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy
Institute of Oncology
Ljubljana, Slovenia
RECRUITINGcomplete 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.
Time frame: 2 weeks after completiton of TNT
Overall survival
time from randomization to death
Time frame: after 3 years of follow-up
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.
Time frame: after 3 years of follow-up
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
Time frame: after 3 years of follow-up
local control
the time from the end of the treatment (in the case of cCR) or surgery to local recurrence
Time frame: after 3 years of follow-up
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