protocolSection identificationModule nctId: NCT06310564, orgStudyIdInfo id: 2023-18, briefTitle: Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy, acronym: GREENLaIT-SABR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2031-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: 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 termthus 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 diseaseThe 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., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: SABR, outcomesModule primaryOutcomes measure: Progression-free survival (PFS)., secondaryOutcomes measure: Time to the polymetastatic conversion (tPMC), secondaryOutcomes measure: Local control (LC): the time between randomization to the date of radiological development of local progression after SABR., secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Time to start of the next systemic treatment line (NEST), secondaryOutcomes measure: Number of adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Number of acute side-effects, secondaryOutcomes measure: Number of Late side-effects, secondaryOutcomes measure: questionnaire QLQ-C30, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria di Negrar, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Luca Nicosia, Doctor, role: CONTACT, phone: +39(0)456014800, email: luca.nicosia@sacrocuore.it, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False