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

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

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to delivering chemotherapy as part of a full pre-surgery treatment plan (total neoadjuvant therapy) for high-risk rectal cancer: giving chemotherapy before radiation (induction) versus after radiation (consolidation). The goal is to find out which sequence better shrinks the tumor and reduces the risk of cancer coming back. **You may be eligible if...** - You have confirmed rectal cancer (adenocarcinoma) with no spread to distant organs - Your MRI shows at least one high-risk feature: large tumor (T4), many lymph nodes involved (N2), tumor growing into blood vessels, positive lateral lymph nodes, or tumor very close to the mesorectal boundary - You are willing to attend regular check-ups **You may NOT be eligible if...** - You have received prior pelvic radiation - You have cancer spread to other organs - You have inflammatory bowel disease - MRI is contraindicated for you - You have a second cancer at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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