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

Albert Lisbona¹  Vincent Marchesi²  Jean-Christophe Faivre²  Julia Salleron³  Marianne Leheurteur⁴  Stéphane Culine⁵  Jean Tredaniel⁶  Sébastien Thureau⁷  Bernard Dubray⁷  Marie-Hélène Vieillard⁸  Lionel Perrier⁹  Naïma Bonnet^1,10  Bernard Asselain^1,10 

[1] Academic Radiation Oncology & Brachytherapy Department, Institut de Cancérologie de l’Ouest – René Gauducheau Comprehensive Cancer Center, Boulevard Professeur Jacques Monod, 44805, Saint-Herblain, France;Academic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandœuvre-lès-Nancy, France;Biostatistics Department, Institut de Cancérologie de Lorraine - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, F-54519, Vandœuvre-lès-Nancy, France;Medical Oncology Department, Henri-Becquerel Comprehensive Cancer Center, rue d’Amiens, 76000, Rouen, France;Medical Oncology Department, University Hospital of Paris (Saint-Louis Hospital), 1 avenue Claude Vellefaux, 75010, Paris, France;Paris Diderot University, 16 rue Huchard, 75018, Paris, France;Pneumology Department, University Hospital of Paris (Groupe hospitalier Paris Saint-Joseph), 185 Rue Raymond Losserand, 75014, Paris, France;Radiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d’Amiens, F-76 000, Rouen, France;EA4108 QuantIf Litis, University of Rouen, 22 boulevard Gambetta, 76000, Rouen, 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;Unicancer, 101, rue de Tolbiac, F-75654, Paris, France;

关键词: MeSH: Oligometastases;    Bone metastases;    Stereotactic radiotherapy;    Neoplasm metastasis;    Radiosurgery;    Lung neoplasms;    Prostatic neoplasms;    Breast neoplasms;   

DOI  :  10.1186/s12885-021-07828-2

来源: Springer

【 摘 要 】

BackgroundStereotactic 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.MethodsThis 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.DiscussionThe 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.Trials registrationClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study

【 授权许可】

CC BY