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

NCT03143322 | Active Not Recruiting DMC

• 1 other identifier: UC-0107/1603
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 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.

Conditions

Metastatic Breast Cancer; Metastatic Lung Cancer; Metastatic Prostate Cancer; Bone Metastases

Keywords

Bone-only metastases; solid tumors; SBRT

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

Study Arms (2)

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.

Radiation: SBRT

Systemic treatment

NO INTERVENTION

Palliative radiotherapy on bone metastases is allowed if necessary (pain, fracture, spinal cord compression…)

Interventions

SBRT RADIATION

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

Systemic treatment + SBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.).

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (28)

ICO - Site Paul Papin

Angers, France

Location

Centre Marie Curie

Arras, France

Location

Hôpital Privé Les Bonnettes

Arras, France

Location

Institut Sainte Catherine

Avignon, France

Location

Centre Pierre Curie

Beuvry, France

Location

Clinique Ambroise Pare

Beuvry, France

Location

Clinique Tivoli Ducos

Bordeaux, France

Location

Institut Bergonié

Bordeaux, France

Location

Hôpital Métropole Savoie

Chambéry, France

Location

Pôle Leonard de Vinci

Chambray-lès-Tours, France

Location

Centre Amethyst CROM

Creil, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Centre Léonard de Vinci

Dechy, France

Location

Institut de Cancérologie de Bourgogne

Dijon, France

Location

Chu Grenoble

Grenoble, France

Location

Centre Oscar Lambret

Lille, France

Location

Hôpital Privé Le Bois

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Centre de Cancérologie du Grand Montpellier

Montpellier, France

Location

Institut de Cancérologie de Lorraine

Nancy, France

Location

Institut de Cancérologie de l'Ouest

Nantes, France

Location

Centre Catalan D'Oncologie

Perpignan, France

Location

Institut Jean Godinot

Reims, France

Location

Centre Henri Becquerel

Rouen, France

Location

Centre d'oncologie et radiothérapie Saint-Jean

Saint-Doulchard, France

Location

GCS RISSA - Institut de cancérologie Paris Nord

Sarcelles, France

Location

Clinique des dentellières

Valenciennes, France

Location

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: 33541288 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sebastien Thureau, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

• Jean-Christophe Faivre, MD

  Institut de Cancérologie de Lorraine - Alexis Vautrin

  PRINCIPAL INVESTIGATOR

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

Locations

FR (28)