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RecruitingPhase 2NCT05054959

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

Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)

Sponsor

Institute of Oncology Ljubljana

Enrollment

62 participants

Start Date

Jun 24, 2021

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

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

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria4

  • absolute contraindications for MR imaging
  • distant metastases cannot be reliably excluded
  • synchronous cancer
  • chronic inflammatory bowel disease

Interventions

OTHERconsolidation chemotherapy

6 cycles CAPOX after chemoradiotherapy

OTHERinduction chemotherapy

4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy

Locations(1)

Institute of Oncology

Ljubljana, Slovenia

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NCT05054959

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