Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06310564

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

Led by IRCCS Sacro Cuore Don Calabria di Negrar · Updated on 2024-12-02

204

Participants Needed

1

Research Sites

367 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6518 years
  • Histologically confirmed colorectal cancer
  • Low or intermediate risk oligometastatic colorectal cancer with 1 to 3 metastases
  • Candidate for first or second line systemic treatment
  • Controlled primary tumor regardless of prior surgery or systemic treatment
  • ECOG/WHO performance status 0 to 2
  • Life expectancy greater than 6 months
  • Lesions 5 cm or smaller
  • Adequate organ function per local guidelines
  • For liver metastases: no cirrhosis or hepatitis and adequate liver function
  • Unresectable liver metastases or refusal of liver surgery before screening
  • Willing to use effective contraception if of childbearing potential
  • Signed informed consent and willingness to follow trial procedures
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Brain metastases
  • More than 3 metastases
  • Malignant pleural effusion or ascites
  • Unable to undergo CT or MRI imaging
  • Medical conditions interfering with treatment or compliance
  • Pregnancy or breastfeeding

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Trial Site Locations

Total: 1 location

1

IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy, 37024

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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