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RECRUITINGPhase 2NCT05054959

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

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

Lead sponsor: Institute of Oncology Ljubljana•1 locations•View source on ClinicalTrials.gov

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Contacts

Vaneja Velenik, PhD

CONTACT

+386 15879297 vvelenik@onko-i.si

Miha Orazem, MD

CONTACT

+386 58792941 morazem@oko-i.si

Sponsors

Lead Sponsor

Institute of Oncology Ljubljana

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 23, 2021Terms

Trial snapshot

StatusRECRUITING

PhasePHASE2

Enrollment62

Start dateJun 2021

Last updatedSep 23, 2021

Condition

Locally Advanced Rectal Cancer

Locations shown

Institute of Oncology

Ljubljana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2021Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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