Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

  • End date
    Dec 31, 2027
  • participants needed
  • sponsor
    Institute of Oncology Ljubljana
Updated on 29 September 2021


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.

Condition Locally Advanced Rectal Cancer
Treatment induction chemotherapy, Consolidation chemotherapy
Clinical Study IdentifierNCT05054959
SponsorInstitute of Oncology Ljubljana
Last Modified on29 September 2021


Yes No Not Sure

Inclusion Criteria

histologically proven rectal adenocarcinoma
no distant metastases on CT scan (M0 disease)
at least one high risk factor for disease recurrence identified on MR imaging
T4 tumor (cT4)
N2 disease (cN2)
extramural venous invasion (cEMVI+)
positive lateral lymph nodes
distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)
capacity for informed consent
willingness to attend regular check-ups during and after treatment

Exclusion Criteria

history of previous irradiation in the pelvic area
absolute contraindications for MR imaging
distant metastases cannot be reliably excluded
synchronous cancer
chronic inflammatory bowel disease
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