Colorectal CancerGREENLaIT-SABRNCT06310564
Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy
A study testing SABR in people with Colorectal Cancer, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SABR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2024to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria di Negrar
Negrar, Verona, 37024
Luca Nicosia, Doctor, +39(0)456014800, luca.nicosia@sacrocuore.it
About this study
Official title: A Prospective, Randomized Clinical Trial of Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy: GREEN LaIT-SABR Study
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:
Read more
- 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
- Colorectal Cancer
- Being tested
- SABR
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SABRRadiation
A biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected [10]; if not possible, a BED schedule no lower than 100 Gy10 should be administered. In compliance with these instructions, treatment schedules, total dose and fractionation will be prescribed according to the clinical practice of each participating Center. The constraints for the organs at risk will be respected according to the available data.
In any case, biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected; if not possible, a BED schedule no lower than 100 Gy10 should be administered.
SABR will be administered before systemic treatment start, or before starting the second systemic treatment cycle at the latest.
| Study group | Role | What they receive |
|---|---|---|
| stereotactic ablative radiotherapy (SABR) | Experimental | SABR to all the active sites of disease (1-3 oligometastases). 3D-CRT, IMRT and VMAT techniques are allowed, but IMRT and VMAT are strongly suggested. Receives: Radiation: SABR |
| no SABR | No intervention | no SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS).
PFS is defined as the time between randomization to the radiological evidence of disease progression.
For patients with a PFS event, PFS will be calculated as the time interval from the date of randomization to the date of first objective evidence of disease progression or death from any cause, whichever occurs first.
For patients without a PFS event, PFS will be censored at the date of the last radiographic assessment prior to the date of study end.
Measured: 7 years
Secondary outcomes (8)
Time to the polymetastatic conversion (tPMC)
tPMC will be defined as the time between randomization to the date of radiological occurrence of >5 new metastases. For patients without a tPMC event, time to tPMC will be censored at the date of the last radiographic assessment prior to the study end date.
Measured: 7 years
Local control (LC): the time between randomization to the date of radiological development of local progression after SABR.
For patients without LC, time to LC will be censored at the date of the last radiographic assessment prior to the study end date.
Measured: 7 years
Overall survival (OS)
OS will be defined as the time between randomization to the date of death or last follow-up. For patients who are alive at the time of the study end date, OS time will be censored on the last date the patient is known to be alive or the study end date, whichever occurs first.
Measured: 7 years
Time to start of the next systemic treatment line (NEST)
For patients without a NEST, time to NEST will be censored at the date of the last patient visit before the study end date.
Measured: 7 years
Number of adverse events as assessed by CTCAE v4.0
Number of adverse events as assessed by CTCAE v4.0
Measured: 60 months
Number of acute side-effects
Acute side-effects
Measured: from enrollment until 6 months after the last dose of SABR
Number of Late side-effects
Late side-effects
Measured: from the 6 months after the last dose of SABR until up to 3 years after inclusion in the trial
questionnaire QLQ-C30
Quality of life (QoL): QoL will be evaluate with the questionnaire QLQ-C30
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start18 Mar 2024
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310564
- Sponsor's protocol ID
- 2023-18
- Acronym
- GREENLaIT-SABR
- Status last verified
- Nov 2024
- First submitted
- 7 Mar 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial of Low and Intermediate Risk OliGometastatic ColoREctal CancEr PatieNts Treated with Stereotactic ABlative Radiotherapy: GREEN LaIT-SABR Study
- ClinicalTrials.gov ID
- NCT06310564
- Acronym / sponsor ID
- GREENLaIT-SABR / 2023-18
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stereotactic ablative radiotherapy (SABR) | Experimental | Radiation: SABRSABR to all the active sites of disease (1-3 oligometastases). 3D-CRT, IMRT and VMAT techniques are allowed, but IMRT and VMAT are strongly suggested. |
| no SABR | No intervention | –no SABR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SABRA biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected [10]; if not possible, a BED schedule no lower than 100 Gy10 should be administered. In compliance with these instructions, treatment schedules, total dose and fractionation will be prescribed according to the clinical practice of each participating Center. The constraints for the organs at risk will be respected according to the available data. In any case, biological effective dose (BED) ≥125 Gy10 should be administered when constraints to the organs at risk (OARs) are respected; if not possible, a BED schedule no lower than 100 Gy10 should be administered. SABR will be administered before systemic treatment start, or before starting the second systemic treatment cycle at the latest. | Radiation | stereotactic ablative radiotherapy (SABR) |
Primary outcome
Progression-free survival (PFS).
Time frame: 7 years
PFS is defined as the time between randomization to the radiological evidence of disease progression. For patients with a PFS event, PFS will be calculated as the time interval from the date of randomization to the date of first objective evidence of disease progression or death from any cause, whichever occurs first. For patients without a PFS event, PFS will be censored at the date of the last radiographic assessment prior to the date of study end.
8 secondary outcomes
Time to the polymetastatic conversion (tPMC)
Time frame: 7 years
Local control (LC): the time between randomization to the date of radiological development of local progression after SABR.
Time frame: 7 years
Overall survival (OS)
Time frame: 7 years
Time to start of the next systemic treatment line (NEST)
Time frame: 7 years
Number of adverse events as assessed by CTCAE v4.0
Time frame: 60 months
Number of acute side-effects
Time frame: from enrollment until 6 months after the last dose of SABR
Number of Late side-effects
Time frame: from the 6 months after the last dose of SABR until up to 3 years after inclusion in the trial
questionnaire QLQ-C30
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SABR in people with Colorectal Cancer, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS). (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.