NCT06310564Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 18 Mar 2024
- Primary completion date
- Apr 2031
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Diseases
- Colorectal cancer
- NCT number
- NCT06310564
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 18 Mar 2024 to the primary completion date, Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Malignant pleural effusion or ascites
Lab values
- 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.
Age
- Age \< 18 years
Other
- Brain metastases
- Having more than 3 metastases
- Unable to undergo imaging by either CT scan or MRI
- Pregnancy or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Sacro Cuore Don Calabria di Negrar Coordinator of this site? Confirm its status | Negrar | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.