Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases
STEREO-OS
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
1 other identifier
interventional
168
1 country
28
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedStudy Start
First participant enrolled
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
ExpectedNovember 26, 2025
November 1, 2025
7 years
April 28, 2017
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (9)
PFS at 2 and 3 years
2 years and 3 years after treatment
Bone progression free survival at 1, 2 and 3 years
1, 2 and 3 years after treatment
Local control at 1, 2 and 3 years
1, 2 and 3 years after treatment
Cancer-specific survival
1, 2 and 3 years after treatment
Overall survival
1, 2 and 3 years after treatment
- +4 more secondary outcomes
Study Arms (2)
Systemic treatment + SBRT
EXPERIMENTALSystemic 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 INTERVENTIONPalliative radiotherapy on bone metastases is allowed if necessary (pain, fracture, spinal cord compression…)
Interventions
SBRT will be added to systemic (standard) treatment of bone metastases.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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 radiotherapy on bone metastasis (e.g: antalgic radiotherapy)
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (28)
ICO - Site Paul Papin
Angers, France
Centre Marie Curie
Arras, France
Hôpital Privé Les Bonnettes
Arras, France
Institut Sainte Catherine
Avignon, France
Centre Pierre Curie
Beuvry, France
Clinique Ambroise Pare
Beuvry, France
Clinique Tivoli Ducos
Bordeaux, France
Institut Bergonié
Bordeaux, France
Hôpital Métropole Savoie
Chambéry, France
Pôle Leonard de Vinci
Chambray-lès-Tours, France
Centre Amethyst CROM
Creil, France
Hôpital Henri Mondor
Créteil, France
Centre Léonard de Vinci
Dechy, France
Institut de Cancérologie de Bourgogne
Dijon, France
Chu Grenoble
Grenoble, France
Centre Oscar Lambret
Lille, France
Hôpital Privé Le Bois
Lille, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
Institut de Cancérologie de Lorraine
Nancy, France
Institut de Cancérologie de l'Ouest
Nantes, France
Centre Catalan D'Oncologie
Perpignan, France
Institut Jean Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Centre d'oncologie et radiothérapie Saint-Jean
Saint-Doulchard, France
GCS RISSA - Institut de cancérologie Paris Nord
Sarcelles, France
Clinique des dentellières
Valenciennes, France
Related Publications (1)
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.
PMID: 33541288DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien Thureau, MD
Centre Henri Becquerel
- PRINCIPAL INVESTIGATOR
Jean-Christophe Faivre, MD
Institut de Cancérologie de Lorraine - Alexis Vautrin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 8, 2017
Study Start
July 24, 2018
Primary Completion
July 31, 2025
Study Completion (Estimated)
July 31, 2027
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share