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

RECRUITINGPhase 2Sponsored by Institute of Oncology Ljubljana
Actively Recruiting
PhasePhase 2
SponsorInstitute of Oncology Ljubljana
Started2021-06-24
Est. completion2022-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerLocally Advanced Rectal Cancer

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