Metastatic Breast CancerSTEREO-OSNCT03143322
Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases
A study testing SBRT in people with Metastatic Breast Cancer and Metastatic Lung Cancer, run by UNICANCER at 28 sites in France.
Trial summary
Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Lung Cancer, Metastatic Prostate Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 28 sitesFrance
- Study dates
- 24 Jul 2018to 31 Jul 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years and younger than 75 years
- Good general condition: WHO performance status ≤ 2
- Patients with histological proof of breast, non-small cell lung, or prostate cancer Note: Histological proof can be done on the primitive tumour and/or adenopathy and/or metastatic site.
- Absence of co-morbidity contra-indicating radio-chemotherapy or surgery
- Primary tumor accessible to curative-intent treatment (surgery, chemoradiation…) for patients with synchronous metastases
- Patients with between 1 and 5 synchronous or metachronous bone metastases as defined by NaF-PET or conventional SPECT-CT scan and spinal MRI (if necessary) within 6 weeks before randomization)
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- Bones metastases treatable by SBRT
- Primary cancer considered to be controlled or accessible to curative-intent treatment (surgery, chemoradiation…) in case of locoregional recurrence for metachronous bone oligo-metastatic disease
- Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
- Patients who have received the information sheet, dated and signed the informed consent form
- Affiliated to the social security system
Who cannot join
- Visceral metastases as defined by FDG-PET (F-Choline-PET or PSMA PET-CT for prostate cancer) and cerebral CT or MRI performed.
- Previous systemic therapy for metastasis for patients with metachronous metastasis. Prostate and breast cancer patients remain eligible if hormonal treatment was initiated 6 months before enrollment
- All bone metastasis requiring surgical treatment (spinal cord compression, fracture…)
- More than 5 bone metastases as defined by NaF-PET or conventional SPECT-CT scan and spinal MRI (if spinal bone metastases on NaF-PET)
- Previous cancer within the 5 years before inclusion (except basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix)
- Previous radiotherapy on bone metastasis (e.g: antalgic radiotherapy)
Show all 11Show fewer
- Patient enrolled in another therapeutic trial
- Pregnant women or breast feeding mothers,
- Hypersensitivity to the active substance (FDG and NaF or F-Choline or PSMA for prostate cancer) or to any of the excipients
- Contraindication to MRI (in case of spinal metastases)
- Patients deprived of liberty or placed under the authority of a tutor. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Patients unable to understand the purpose of the study (language, etc.).
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
ICO - Site Paul Papin
Angers
Centre Marie Curie
Arras
Hôpital Privé Les Bonnettes
Arras
Institut Sainte Catherine
Avignon
Centre Pierre Curie
Beuvry
Clinique Ambroise Pare
Beuvry
Clinique Tivoli Ducos
Bordeaux
Institut Bergonié
Bordeaux
Hôpital Métropole Savoie
Chambéry
Pôle Leonard de Vinci
Chambray-lès-Tours
Centre Amethyst CROM
Creil
Hôpital Henri Mondor
Créteil
Centre Léonard de Vinci
Dechy
Institut de Cancérologie de Bourgogne
Dijon
Chu Grenoble
Grenoble
Centre Oscar Lambret
Lille
Hôpital Privé Le Bois
Lille
Centre Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille
Centre de Cancérologie du Grand Montpellier
Montpellier
Institut de Cancérologie de Lorraine
Nancy
Institut de Cancérologie de l'Ouest
Nantes
Centre Catalan D'Oncologie
Perpignan
Institut Jean Godinot
Reims
Centre Henri Becquerel
Rouen
Centre d'oncologie et radiothérapie Saint-Jean
Saint-Doulchard
GCS RISSA - Institut de cancérologie Paris Nord
Sarcelles
Clinique des dentellières
Valenciennes
About this study
Official title: Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases
Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis).
The concept of "oligometastases" was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies.
Read more
Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient's quality of life and autonomy, and their accessibility to potentially curative radiotherapy.
The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers).
Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy.
In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 5 metastases) in solid tumor patients is able to improve the survival without progression.
- Conditions
- Metastatic Breast Cancer, Metastatic Lung Cancer, Metastatic Prostate Cancer, Bone Metastases
- Being tested
- SBRT
- Keywords
- Bone-only metastases, solid tumors, SBRT
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
SBRT will be added to systemic (standard) treatment of bone metastases.
| Study group | Role | What they receive |
|---|---|---|
| Systemic treatment + SBRT | Experimental | Systemic treatment and SBRT to the bone metastases. Two SBRT schemes are allowed: 9 Gy x 3 fractions or 7 Gy x 5 fractions for axial and appendicular bones metastases. The choice is at the discretion of the investigator. Receives: Radiation: SBRT |
| Systemic treatment | No intervention | Palliative radiotherapy on bone metastases is allowed if necessary (pain, fracture, spinal cord compression…) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To evaluate the impact of SBRT on Progression-Free Survival (PFS) at 1 year according to RECIST 1.1 and PERCIST 1.0 Criteria
Measured: 1 year
Secondary outcomes (9)
PFS at 2 and 3 years
Progression-Free Survival (PFS) at 2 and 3 years will be evaluated according to RECIST 1.1 and PERCIST
Measured: 2 years and 3 years after treatment
Bone progression free survival at 1, 2 and 3 years
Distant bone progression at 2 and 3 years will be evaluated according to RECIST Criteria 1.1 and at 1 year according to RECIST Criteria 1.1 and PERCIST
Measured: 1, 2 and 3 years after treatment
Local control at 1, 2 and 3 years
Local control will be evaluated at 1, 2 and 3 years according to RECIST Criteria 1.1 and PERCIST
Measured: 1, 2 and 3 years after treatment
Cancer-specific survival
The length of time from the start of treatment for the disease until the death identified as being due to the specified cancer.
Measured: 1, 2 and 3 years after treatment
Overall survival
The length of time from the start of treatment for the disease until patients are still alive.
Measured: 1, 2 and 3 years after treatment
SBRT toxicities
according CTCAE 4.0 scale
Measured: 1, 2 and 3 years after treatment
Patient's Quality of life
self-administered questionnaire
Measured: at baseline, 6 weeks after randomization, and 3 months, 6 months and 1, 2 and 3 years after treatment
Pain score
according to Numeric Scale related to pain medication
Measured: at baseline, once a week during 2 weeks and 6 weeks after randomization, and at 3 months, 6 months and 1, 2 and 3 years after treatment
Cost utility
QALYs (Quality-Adjusted Life Years) and ICERs (Incremental Cost-Effectiveness Ratios) calculation based on EQ-5D-3L questionnaire.
Measured: 6 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start24 Jul 2018
- Primary completion31 Jul 2025
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Thureau, MD, Principal investigator, Centre Henri BecquerelJean-Christophe Faivre, MD, Principal investigator, Institut de Cancérologie de Lorraine - Alexis Vautrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143322
- Sponsor's protocol ID
- UC-0107/1603
- Acronym
- STEREO-OS
- Status last verified
- Nov 2025
- First submitted
- 28 Apr 2017
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thureau S, Marchesi V, Vieillard MH, Perrier L, Lisbona A, Leheurteur M, Tredaniel J, Culine S, Dubray B, Bonnet N, Asselain B, Salleron J, Faivre JC. Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). BMC Cancer. 2021 Feb 4;21(1):117. doi: 10.1186/s12885-021-07828-2.
PubMed 33541288
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases
- ClinicalTrials.gov ID
- NCT03143322
- Acronym / sponsor ID
- STEREO-OS / UC-0107/1603
- Conditions
- Metastatic Breast Cancer, Metastatic Lung Cancer, Metastatic Prostate Cancer, Bone Metastases
- Keywords
- Bone-only metastases, solid tumors, SBRT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 May 2017 (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.
Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis).
The concept of "oligometastases" was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies.
Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient's quality of life and autonomy, and their accessibility to potentially curative radiotherapy.
The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers).
Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy.
In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 5 metastases) in solid tumor patients is able to improve the survival without progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic treatment + SBRT | Experimental | Radiation: SBRTSystemic treatment and SBRT to the bone metastases. Two SBRT schemes are allowed: 9 Gy x 3 fractions or 7 Gy x 5 fractions for axial and appendicular bones metastases. The choice is at the discretion of the investigator. |
| Systemic treatment | No intervention | –Palliative radiotherapy on bone metastases is allowed if necessary (pain, fracture, spinal cord compression…) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients older than 18 years and younger than 75 years
- Good general condition: WHO performance status ≤ 2
- Patients with histological proof of breast, non-small cell lung, or prostate cancer Note: Histological proof can be done on the primitive tumour and/or adenopathy and/or metastatic site.
- Absence of co-morbidity contra-indicating radio-chemotherapy or surgery
- Primary tumor accessible to curative-intent treatment (surgery, chemoradiation…) for patients with synchronous metastases
Key exclusion criteria (11 listed)
- Visceral metastases as defined by FDG-PET (F-Choline-PET or PSMA PET-CT for prostate cancer) and cerebral CT or MRI performed.
- Previous systemic therapy for metastasis for patients with metachronous metastasis. Prostate and breast cancer patients remain eligible if hormonal treatment was initiated 6 months before enrollment
- All bone metastasis requiring surgical treatment (spinal cord compression, fracture…)
- More than 5 bone metastases as defined by NaF-PET or conventional SPECT-CT scan and spinal MRI (if spinal bone metastases on NaF-PET)
- Previous cancer within the 5 years before inclusion (except basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix)
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 |
|---|---|---|
| SBRTSBRT will be added to systemic (standard) treatment of bone metastases. | Radiation | Systemic treatment + SBRT |
Primary outcome
Progression Free Survival
Time frame: 1 year
To evaluate the impact of SBRT on Progression-Free Survival (PFS) at 1 year according to RECIST 1.1 and PERCIST 1.0 Criteria
9 secondary outcomes
PFS at 2 and 3 years
Time frame: 2 years and 3 years after treatment
Bone progression free survival at 1, 2 and 3 years
Time frame: 1, 2 and 3 years after treatment
Local control at 1, 2 and 3 years
Time frame: 1, 2 and 3 years after treatment
Cancer-specific survival
Time frame: 1, 2 and 3 years after treatment
Overall survival
Time frame: 1, 2 and 3 years after treatment
SBRT toxicities
Time frame: 1, 2 and 3 years after treatment
Patient's Quality of life
Time frame: at baseline, 6 weeks after randomization, and 3 months, 6 months and 1, 2 and 3 years after treatment
Pain score
Time frame: at baseline, once a week during 2 weeks and 6 weeks after randomization, and at 3 months, 6 months and 1, 2 and 3 years after treatment
Cost utility
Time frame: 6 weeks after randomization
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 26 Nov 2025.
- Derived from this study: PubMed 33541288Thureau S, Marchesi V, Vieillard MH, Perrier L, Lisbona A, Leheurteur M, Tredaniel J, Culine S, Dubray B, Bonnet N, Asselain B, Salleron J, Faivre JC. Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). BMC Cancer. 2021 Feb 4;21(1):117. doi: 10.1186/s12885-021-07828-2.
- 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. This study is not recruiting at the moment.
Sebastien Thureau, MD principal investigator
Centre Henri Becquerel
Jean-Christophe Faivre, MD principal investigator
Institut de Cancérologie de Lorraine - Alexis Vautrin
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Metastatic Breast Cancer and Metastatic Lung Cancer, run by UNICANCER at 28 sites in France.
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 11 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143322, which also lists 1 linked publication.
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 26 Nov 2025.