RecruitingNot ApplicableNCT06310564

Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy

A Prospective, Randomized Clinical Trial of Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy: GREEN LaIT-SABR Study


Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrollment

204 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers. The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to: * delay possible local recurrence and/or distant polymetastatic progression * improve disease-free survival * reduce side effects in the short and long term thus inducing an improvement in the quality of life of patients suffering from this type of pathology. Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms: * Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy) * Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic disease The procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose \>100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same). It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests stereotactic ablative radiotherapy (SABR) — a precise, high-dose radiation technique — in patients with low or intermediate risk oligometastatic colorectal cancer, meaning colorectal cancer that has spread to only a small number of spots (1 to 3 metastases). The goal is to treat all visible disease sites while patients are also receiving standard chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with colorectal cancer (confirmed by biopsy) that has spread to 1 to 3 metastatic sites - Your metastatic lesions are each 5 cm or smaller - Your primary bowel tumor is under control - You are in good general health (ECOG 0–2) - Your life expectancy is greater than 6 months **You may NOT be eligible if...** - You have more than 3 metastases or widespread disease - Your liver metastases are eligible for surgical removal and you agree to surgery - You have active hepatitis or liver cirrhosis (for liver metastases) - You are pregnant 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

RADIATIONSABR

A biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected \[10\]; if not possible, a BED schedule no lower than 100 Gy10 should be administered. In compliance with these instructions, treatment schedules, total dose and fractionation will be prescribed according to the clinical practice of each participating Center. The constraints for the organs at risk will be respected according to the available data. In any case, biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected; if not possible, a BED schedule no lower than 100 Gy10 should be administered. SABR will be administered before systemic treatment start, or before starting the second systemic treatment cycle at the latest.


Locations(1)

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

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NCT06310564


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