Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases

Metastatic Breast Cancer Clinical Trial

— STEREO-OS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03143322
• Other study ID #: UC-0107/1603
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: July 24, 2027

Study information

• Verified date: December 2023
• Source: UNICANCER
• Contact: Saliha GHANEM, PhD
• Phone: +33(0)1 80 50 12 98
• Email: s-ghanem[@]unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: July 24, 2027
• Est. primary completion date: January 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients older than 18 years and younger than 75 years

2. Good general condition: WHO performance status = 2

3. 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.

4. Absence of co-morbidity contra-indicating radio-chemotherapy or surgery

5. Primary tumor accessible to curative-intent treatment (surgery, chemoradiation…) for patients with synchronous metastases

6. 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)

7. Bones metastases treatable by SBRT

8. 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

9. 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

10. Patients who have received the information sheet, dated and signed the informed consent form

11. Affiliated to the social security system

Exclusion Criteria:

1. Visceral metastases as defined by FDG-PET (F-Choline-PET or PSMA PET-CT for prostate cancer) and cerebral CT or MRI performed.

2. 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

3. All bone metastasis requiring surgical treatment (spinal cord compression, fracture…)

4. 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)

5. Previous cancer within the 5 years before inclusion (except basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix)

6. Previous radiotherapy on bone metastasis (e.g: antalgic radiotherapy)

7. Patient enrolled in another therapeutic trial

8. Pregnant women or breast feeding mothers,

9. Hypersensitivity to the active substance (FDG and NaF or F-Choline or PSMA for prostate cancer) or to any of the excipients

10. Contraindication to MRI (in case of spinal metastases)

11. 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.).

Related Conditions & MeSH terms

• Bone Metastases
• Metastatic Breast Cancer
• Metastatic Lung Cancer
• Metastatic Prostate Cancer
• Neoplasm Metastasis

Intervention

Radiation:
• SBRT
SBRT will be added to systemic (standard) treatment of bone metastases.

Locations

Country	Name	City	State
France	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	Centre Georges Francois Leclerc	Dijon
France	Institut de Cancérologie de Bourgogne	Dijon
France	Chu Grenoble	Grenoble
France	Centre de Radiothérapie Hartmann	Levallois Perret
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 Eugène Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre d'oncologie et radiothérapie Saint-Jean	Saint-doulchard
France	CHU Saint-Etienne	Saint-Étienne
France	GCS RISSA - Institut de cancérologie Paris Nord	Sarcelles
France	Centre Marie Curie	Valence
France	Clinique des dentellières	Valenciennes
France	Centre d'Oncologie Saint Yves	Vannes

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 years and 3 years after treatment
Secondary	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	1, 2 and 3 years after treatment
Secondary	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	1, 2 and 3 years after treatment
Secondary	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.	1, 2 and 3 years after treatment
Secondary	Overall survival	The length of time from the start of treatment for the disease until patients are still alive.	1, 2 and 3 years after treatment
Secondary	SBRT toxicities	according CTCAE 4.0 scale	1, 2 and 3 years after treatment
Secondary	Patient's Quality of life	self-administered questionnaire	at baseline, 6 weeks after randomization, and 3 months, 6 months and 1, 2 and 3 years after treatment
Secondary	Pain score	according to Numeric Scale related to pain medication	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
Secondary	Cost utility	QALYs (Quality-Adjusted Life Years) and ICERs (Incremental Cost-Effectiveness Ratios) calculation based on EQ-5D-3L questionnaire.	6 weeks after randomization