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 tr

Stereotactic Body Radiation Therapy (SBRT) is an innovative modality based on high precision planning and delivery. Cancer with bone metastases and oligometastases are associated with an intermediate or good prognosis. We assume that prolonged survival rates would be achieved if both the primary tumor and metastases are controlled by local treatment. Our purpose is to demonstrate, via a multicenter randomized phase III trial, that local treatment of metastatic sites with curative intent with SBRT associated of systemic standard of care treatment would improve the progression-free survival in patients with solid tumor (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases compared to patients who received systemic standard of care treatment alone.

This is an open-labeled randomized superiority multicenter phase III trial. Patients with up to 3 bone-only metastases will be randomized in a 1:1 ratio.between Arm A (Experimental group): Standard care of treatment & SBRT to all bone metastases, and Arm B (Control group): standard care of treatment. For patients receiving SBRT, radiotherapy dose and fractionation depends on the site of the bone metastasis and the proximity to critical normal structures. This study aims to accrue a total of 196 patients within 4 years. The primary endpoint is progression-free survival at 1 year, and secondary endpoints include Bone progression-free survival; Local control; Cancer-specific survival; Overall survival; Toxicity; Quality of life; Pain score analysis, Cost-utility analysis; Cost-effectiveness analysis and Budget impact analysis.

The expected benefit for the patient in the experimental arm is a longer expectancy of life without skeletal recurrence and the discomfort, pain and drastic reduction of mobility and handicap that the lack of local control of bone metastases eventually inflicts.

ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study.

BMC cancer. 2021 Feb 04*** epublish ***

Sébastien Thureau, Vincent Marchesi, Marie-Hélène Vieillard, Lionel Perrier, Albert Lisbona, Marianne Leheurteur, Jean Tredaniel, Stéphane Culine, Bernard Dubray, Naïma Bonnet, Bernard Asselain, Julia Salleron, Jean-Christophe Faivre

Radiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, F-76 000, Rouen, France. ., Academic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandœuvre-lès-Nancy, France., Rheumatology Department, University Hospital of Lille, 2 avenue Oscar Lambret, 59 000, Lille, France., UMR CNRS 5824, Léon Bérard Comprehensive Cancer Center, 28 rue laennec, 69 373, Lyon, France., Academic Radiation Oncology & Brachytherapy Department, Institut de Cancérologie de l'Ouest - René Gauducheau Comprehensive Cancer Center, Boulevard Professeur Jacques Monod, 44805, Saint-Herblain, France., Medical Oncology Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, 76000, Rouen, France., Pneumology Department, University Hospital of Paris (Groupe hospitalier Paris Saint-Joseph), 185 Rue Raymond Losserand, 75014, Paris, France., Medical Oncology Department, University Hospital of Paris (Saint-Louis Hospital), 1 avenue Claude Vellefaux, 75010, Paris, France., Radiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, F-76 000, Rouen, France., Unicancer, 101, rue de Tolbiac, F-75654, Paris, France., Biostatistics Department, Institut de Cancérologie de Lorraine - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, F-54519, Vandœuvre-lès-Nancy, France.