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Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT05054959•Institute of Oncology Ljubljana

View on ClinicalTrials.gov

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

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Institute of Oncology

Ljubljana, Slovenia

Key Dates

Start Date

June 24, 2021

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2027

Last Updated

September 23, 2021

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

consolidation chemotherapy

OTHER

induction chemotherapy

OTHER

Contacts

Vaneja Velenik, PhD

CONTACT

+386 15879297 vvelenik@onko-i.si

Miha Orazem, MD

CONTACT

+386 58792941 morazem@oko-i.si

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082

Locally Advanced Rectal Cancer

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RECRUITINGPHASE2

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

NCT06204094

Locally Advanced Rectal Cancer

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ACTIVE_NOT_RECRUITINGNA

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

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: March 29, 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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Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Inclusion Criteria

Exclusion Criteria

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.