Stereotactic radiotherapy for patients with low and intermediate risk oligometastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This experimental study evaluates the effectiveness of stereotactic ablative radiotherapy (SABR) combined with systemic chemotherapy in patients with low to intermediate risk oligometastatic colorectal cancer. Participants will be randomized to receive either the experimental SABR treatment or standard care before starting their first or second line of systemic therapy. The study aims to assess whether this approach can delay local recurrence, improve disease-free survival, and reduce side effects, ultimately enhancing the quality of life for patients. The trial is conducted at the IRCCS Sacro Cuore Don Calabria Hospital and 18 other centers across Italy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed CRC
* Low and intermediate risk oligometastatic colorectal cancer with 1 to 3 metastases, candidate to I or II line systemic treatment (Low risk: 1 to 3 metastases and cumulative tumor volume smaller than 10 cm3; Intermediate risk: 1 to 3 metastases and cumulative tumor volume bigger than 10 cm3).
* Controlled primary tumor regardless of primary surgery or primary systemic treatment
* ECOG/WHO 0-2
* Life expectancy \> 6 months
* Lesions ≤ 5 cm
* Adequate organ function for the planned treatment according to local guidelines
* For patients with liver metastases: no cirrhosis or hepatitis, and evidence of adequate hepatic function (Total bilirubin level \< 1.5 x institutional ULN; ALT and AST levels \< 3.0 x institutional ULN, GGT and alkaline phosphatase levels \< 3.0 x institutional ULN; INR and APTT levels \< 1.5 x institutional ULN, Albumin \> 2.5 mg/dL)
* For patients with liver metastases: unresectable liver metastases (assessed by a surgeon, preferably hepatobiliary) or refusal of liver surgery before study screening.
* If childbearing potential, willing to use an effective form of contraception throughout the duration of the study
* Signed informed consent and willingness to follow the trial procedures

Exclusion Criteria:

* Age \< 18 years
* Brain metastases
* Having more than 3 metastases
* Malignant pleural effusion or ascites
* Unable to undergo imaging by either CT scan or MRI
* Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
* Pregnancy or breast-feeding

Where it's running

• IRCCS Sacro Cuore Don Calabria di Negrar
  Negrar, Verona, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.