Breast CancerSPRINTNCT06462963
OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
A study testing single-fraction SBRT and multiple-fraction SBRT in people with Breast Cancer and Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 4 countries.
Trial summary
The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Prostate Cancer, NSCLC
- What is being tested?
- single-fraction SBRT and multiple-fraction SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 15 Apr 2025to 15 Feb 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is part of the RP1822-OligoCare. As in OligoCare, ALL active cancer lesions (loco-regional primary and all oligometastases) were or will be treated with radical intent (surgery or radiotherapy).
- All lesions that will be treated with radical radiotherapy have to be amenable to single-fraction SBRT. Concurrent systemic treatment is allowed.
- Written informed consent must be given according to ICH/GCP, and national/local regulations. Patients will be consented in a step-wise approach.
- Step 1 [both control and experimental arms]: patients will need to consent to be included and evaluated in E²-RADIatE (that includes the non-interventional OligoCare prospective registry cohort) and to potentially be randomized to future sub-studies for which they are eligible; no further consent will be sought if they are randomized to the SoC (control) arm; Step 2 [experimental arm only]: if eligible for the current sub-study and randomized to receive single-fraction SBRT, patients will need to consent to receiving the experimental treatment.
Who cannot join
- All targeted lesion judged by the treating physician to be associated with risks for severe toxicity following single-fraction SBRT. The following lesions are systematically excluded:
- Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus or brachial plexus
- Metastases within < 5 mm of any hollow GI structure: esophagus, stomach, small bowel, large bowel
- Metastases within < 5 mm of the spinal cord, the cauda equina or the brachial plexus
- Metastases > 5 cm in largest diameter.
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 4 countries
Italy6 sites, 6 recruiting
- Not yet recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence
- Not yet recruiting
Istituto Clinico Humanitas
Milan
- Not yet recruiting
Istituto Europeo di Oncologia
Milan
- Not yet recruiting
Sacro Cuore Hospital
Negrar
- Not yet recruiting
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma
- Not yet recruiting
Universita Di Torino
Torino
Belgium5 sites, 5 recruiting
- Not yet recruiting
Onze Lieve Vrouw Ziekenhuis
Aalst
- Not yet recruiting
Institut Jules Bordet
Brussels
- Not yet recruiting
Universitair Ziekenhuis Gent
Ghent
- Not yet recruiting
AZ Groeninge Kortrijk
Kortrijk
- Not yet recruiting
Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus
Wilrijk
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Radiotherapiegroep Arnhem
Deventer
- Not yet recruiting
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital - Inselspital
Bern, 3010
- Recruiting
UniversitaetsSpital Zurich
Zurich, 8901
About this study
The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT.
The main question/hypothesis this clinical trial aims to answer is:
Read more
- Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.
Patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT.
Read the detailed description
As a consequence of improved survival of metastatic cancer patients due to more effective systemic therapy, focused radiotherapy in the form of stereotactic body radiotherapy (SBRT) has become a standard of care in many clinical situations to achieve durable symptom and / or metastasis control: treatment of brain metastases, of painful bone or spinal metastases and especially as local treatment in a multimodality treatment strategy for oligometastatic disease. These indications are supported by international practice guidelines, e.g. ESMO guidelines for NSCLC and colorectal cancer; and NCCN guidelines for NSCLC, prostate cancer, renal cell cancer, colorectal cancer and sarcoma.
However, despite the universal use of SBRT in the local treatment of oligometastases, the level of evidence supporting stereotactic radiotherapy is low, apart from few small prospective clinical trials showing a very favourable toxicity profile of SBRT and promising efficacy data. In this context, the OligoCare research project, a prospective observational cohort study, has been developed within the E²-RADIatE platform. The aim of this project is to collect real-world data on SBRT treatment of patients with oligometastatic disease of primary breast, prostate, lung and colorectal cancer, with no limit on the maximum number of treated metastases.
Yet, the local treatment of multiple metastases poses several challenges. One of them is the integration of local metastases-directed SBRT into a systemic treatment strategy: in an interim analysis of the OligoCare cohort, almost all patients were treated with fractionated SBRT and the median number of SBRT fractions was 5. This would result in a total of 50 SBRT fractions in a patient with 10 metastases. Considering that several drugs are paused before and after SBRT, the systemic therapy free interval could last for almost 2 months, which one could consider as unacceptably long in metastatic cancer patients.
One solution to this problem would be the delivery of radiotherapy in a smaller number of SBRT fractions, preferably as single-fraction SBRT. Single-fraction SBRT has been described since the 90's for treatment of liver metastases, lung metastases or vertebral metastases. A recent randomized phase II trial compared multiple-fraction vs single-fraction SBRT for pulmonary oligometastases (n=90) and did not observe differences in toxicity or any oncological outcome parameter.
Nevertheless, single-fraction SBRT still lacks adoption in the radiation oncology community. Likely reasons are the experience of single-fraction SBRT restricted to small, highly specialized centers, the small number of patients treated with single-fraction SBRT in the literature and the concerns of potentially increased toxicity and / or decreased efficacy.
There is consequently a strong rationale to implement and evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current SoC of multiple-fraction SBRT.
This question will be addressed in the current Trials within Cohorts (TwiCs) study, in which patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT. The main hypothesis is that single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.
- Being tested
- single-fraction SBRT, multiple-fraction SBRT
- Keywords
- radiotherapy, SBRT, TwiCs
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-fraction SBRTRadiation
Single-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers a high dose of radiation in a single treatment session to a targeted area, often used for treating small, well-defined tumors. This approach minimizes exposure to surrounding healthy tissues while effectively treating the tumor.
multiple-fraction SBRTRadiation
Multiple-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers high doses of radiation over several treatment sessions to a targeted area, typically used for treating small, well-defined tumors. This method helps to further protect surrounding healthy tissues by spreading the total radiation dose over multiple sessions.
| Study group | Role | What they receive |
|---|---|---|
| single-fraction SBRT | Experimental | All lesions to be treated with radical radiotherapy will be treated with single-fraction SBRT, delivered using a dose ranging from 16 Gy to 34 Gy, depending on metastasis location. Acceptable ablative doses are developed in the protocol (see Section 6.4).
Radiotherapy treatment will last from one single visit to a few weeks, depending on the number of treated metastases. Receives: Radiation: single-fraction SBRT |
| multiple-fraction SBRT | Active comparator | All lesions to be treated with radical radiotherapy will be treated with multiple-fraction SBRT. Receives: Radiation: multiple-fraction SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3+ SBRT-related toxicity
The cumulative incidence of grade 3+ SBRT-related toxicity within 12 months following treatment with radical radiotherapy. This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.
Measured: within 12 months following treatment with radical radiotherapy.
Secondary outcomes (4)
Progression free survival (PFS)
defined as the time from the date of randomization to the date of first progression (local, regional or distant) as per local assessment or death.
Measured: 4.5 years from first patient in
Overall survival (OS)
defined as the time from the date of randomization to the date of death from any cause.
Measured: 4.5 years from first patient in
Local control (LC)
defined as freedom from local metastasis (inside the PTV or prior treated field).
Measured: 4.5 years from first patient in
Pattern of progression of primary disease and metastases
Pattern of progression of primary disease and metastases includes local, regional and/or distant progression or recurrence.
Measured: 4.5 years from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start15 Apr 2025
- Primary completion15 Feb 2029 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- 302 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, MD, Principal investigator, Radiation Oncology, University of Zurich, SwitzerlandPiet Ost, MD, Principal investigator, GZA Sint-Augustinus, Wilrijk, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462963
- Sponsor's protocol ID
- EORTC-2387
- Acronym
- SPRINT
- Status last verified
- Jul 2025
- First submitted
- 28 May 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)
- ClinicalTrials.gov ID
- NCT06462963
- Acronym / sponsor ID
- SPRINT / EORTC-2387
- Keywords
- radiotherapy, SBRT, TwiCs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Feb 2029 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 17 Jun 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.
The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT.
The main question/hypothesis this clinical trial aims to answer is:
- Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.
Patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT.
Detailed description
As a consequence of improved survival of metastatic cancer patients due to more effective systemic therapy, focused radiotherapy in the form of stereotactic body radiotherapy (SBRT) has become a standard of care in many clinical situations to achieve durable symptom and / or metastasis control: treatment of brain metastases, of painful bone or spinal metastases and especially as local treatment in a multimodality treatment strategy for oligometastatic disease. These indications are supported by international practice guidelines, e.g. ESMO guidelines for NSCLC and colorectal cancer; and NCCN guidelines for NSCLC, prostate cancer, renal cell cancer, colorectal cancer and sarcoma.
However, despite the universal use of SBRT in the local treatment of oligometastases, the level of evidence supporting stereotactic radiotherapy is low, apart from few small prospective clinical trials showing a very favourable toxicity profile of SBRT and promising efficacy data. In this context, the OligoCare research project, a prospective observational cohort study, has been developed within the E²-RADIatE platform. The aim of this project is to collect real-world data on SBRT treatment of patients with oligometastatic disease of primary breast, prostate, lung and colorectal cancer, with no limit on the maximum number of treated metastases.
Yet, the local treatment of multiple metastases poses several challenges. One of them is the integration of local metastases-directed SBRT into a systemic treatment strategy: in an interim analysis of the OligoCare cohort, almost all patients were treated with fractionated SBRT and the median number of SBRT fractions was 5. This would result in a total of 50 SBRT fractions in a patient with 10 metastases. Considering that several drugs are paused before and after SBRT, the systemic therapy free interval could last for almost 2 months, which one could consider as unacceptably long in metastatic cancer patients.
One solution to this problem would be the delivery of radiotherapy in a smaller number of SBRT fractions, preferably as single-fraction SBRT. Single-fraction SBRT has been described since the 90's for treatment of liver metastases, lung metastases or vertebral metastases. A recent randomized phase II trial compared multiple-fraction vs single-fraction SBRT for pulmonary oligometastases (n=90) and did not observe differences in toxicity or any oncological outcome parameter.
Nevertheless, single-fraction SBRT still lacks adoption in the radiation oncology community. Likely reasons are the experience of single-fraction SBRT restricted to small, highly specialized centers, the small number of patients treated with single-fraction SBRT in the literature and the concerns of potentially increased toxicity and / or decreased efficacy.
There is consequently a strong rationale to implement and evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current SoC of multiple-fraction SBRT.
This question will be addressed in the current Trials within Cohorts (TwiCs) study, in which patients from the OligoCare cohort will be randomized to receive either single-fraction SBRT or the current SoC of multiple-fraction SBRT. The main hypothesis is that single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-fraction SBRT | Experimental | Radiation: single-fraction SBRTAll lesions to be treated with radical radiotherapy will be treated with single-fraction SBRT, delivered using a dose ranging from 16 Gy to 34 Gy, depending on metastasis location. Acceptable ablative doses are developed in the protocol (see Section 6.4). Radiotherapy treatment will last from one single visit to a few weeks, depending on the number of treated metastases. |
| multiple-fraction SBRT | Active comparator | Radiation: multiple-fraction SBRTAll lesions to be treated with radical radiotherapy will be treated with multiple-fraction SBRT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is part of the RP1822-OligoCare. As in OligoCare, ALL active cancer lesions (loco-regional primary and all oligometastases) were or will be treated with radical intent (surgery or radiotherapy).
- All lesions that will be treated with radical radiotherapy have to be amenable to single-fraction SBRT. Concurrent systemic treatment is allowed.
- Written informed consent must be given according to ICH/GCP, and national/local regulations. Patients will be consented in a step-wise approach.
- Step 1 [both control and experimental arms]: patients will need to consent to be included and evaluated in E²-RADIatE (that includes the non-interventional OligoCare prospective registry cohort) and to potentially be randomized to future sub-studies for which they are eligible; no further consent will be sought if they are randomized to the SoC (control) arm; Step 2 [experimental arm only]: if eligible for the current sub-study and randomized to receive single-fraction SBRT, patients will need to consent to receiving the experimental treatment.
Key exclusion criteria (5 listed)
- All targeted lesion judged by the treating physician to be associated with risks for severe toxicity following single-fraction SBRT. The following lesions are systematically excluded:
- Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus or brachial plexus
- Metastases within < 5 mm of any hollow GI structure: esophagus, stomach, small bowel, large bowel
- Metastases within < 5 mm of the spinal cord, the cauda equina or the brachial plexus
- Metastases > 5 cm in largest diameter.
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 |
|---|---|---|
| single-fraction SBRTSingle-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers a high dose of radiation in a single treatment session to a targeted area, often used for treating small, well-defined tumors. This approach minimizes exposure to surrounding healthy tissues while effectively treating the tumor. | Radiation | single-fraction SBRT |
| multiple-fraction SBRTMultiple-fraction SBRT (Stereotactic Body Radiation Therapy) is a precise form of radiation therapy that delivers high doses of radiation over several treatment sessions to a targeted area, typically used for treating small, well-defined tumors. This method helps to further protect surrounding healthy tissues by spreading the total radiation dose over multiple sessions. | Radiation | multiple-fraction SBRT |
Primary outcome
Grade 3+ SBRT-related toxicity
Time frame: within 12 months following treatment with radical radiotherapy.
The cumulative incidence of grade 3+ SBRT-related toxicity within 12 months following treatment with radical radiotherapy. This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting.
4 secondary outcomes
Progression free survival (PFS)
Time frame: 4.5 years from first patient in
Overall survival (OS)
Time frame: 4.5 years from first patient in
Local control (LC)
Time frame: 4.5 years from first patient in
Pattern of progression of primary disease and metastases
Time frame: 4.5 years from first patient in
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 1 Aug 2025.
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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.
Matthias Guckenberger, MD principal investigator
Radiation Oncology, University of Zurich, Switzerland
Piet Ost, MD principal investigator
GZA Sint-Augustinus, Wilrijk, Belgium
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-fraction SBRT and multiple-fraction SBRT in people with Breast Cancer and Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 4 countries.
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 4 inclusion and 5 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 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Belgium, Netherlands, Switzerland. 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?
Contact EORTC HQ (+32 2 774 16 11, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3+ SBRT-related toxicity (time frame: within 12 months following treatment with radical radiotherapy.). 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 1 Aug 2025.