Stereotactic radiotherapy for patients with low and intermediate risk oligometastatic colorectal cancer
A Prospective, Randomized Clinical Trial of Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy: GREEN LaIT-SABR Study
NA · IRCCS Sacro Cuore Don Calabria di Negrar · NCT06310564
This study is testing if a new type of targeted radiation treatment combined with chemotherapy can help people with low to intermediate risk colorectal cancer live longer and feel better compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT06310564 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed low to intermediate risk oligometastatic colorectal cancer and 1 to 3 metastases.
Not a fit: Patients with extensive metastatic disease beyond 3 lesions or those with significant liver cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with oligometastatic colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiotherapy in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria di Negrar — Negrar, Verona, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Cancer