PMID- 33541288 OWN - NLM STAT- MEDLINE DCOM- 20210510 LR - 20210510 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 21 IP - 1 DP - 2021 Feb 4 TI - 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). PG - 117 LID - 10.1186/s12885-021-07828-2 [doi] LID - 117 AB - BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIALS REGISTRATION: ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study. FAU - Thureau, Sebastien AU - Thureau S AD - Radiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, F-76 000, Rouen, France. sebastien.thureau@chb.unicancer.fr. AD - EA4108 QuantIf Litis, University of Rouen, 22 boulevard Gambetta, 76000, Rouen, France. sebastien.thureau@chb.unicancer.fr. FAU - Marchesi, Vincent AU - Marchesi V AD - Academic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandoeuvre-les-Nancy, France. FAU - Vieillard, Marie-Helene AU - Vieillard MH AD - Rheumatology Department, University Hospital of Lille, 2 avenue Oscar Lambret, 59 000, Lille, France. FAU - Perrier, Lionel AU - Perrier L AD - UMR CNRS 5824, Leon Berard Comprehensive Cancer Center, 28 rue laennec, 69 373, Lyon, France. FAU - Lisbona, Albert AU - Lisbona A AD - Academic Radiation Oncology & Brachytherapy Department, Institut de Cancerologie de l'Ouest - Rene Gauducheau Comprehensive Cancer Center, Boulevard Professeur Jacques Monod, 44805, Saint-Herblain, France. FAU - Leheurteur, Marianne AU - Leheurteur M AD - Medical Oncology Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, 76000, Rouen, France. FAU - Tredaniel, Jean AU - Tredaniel J AD - Pneumology Department, University Hospital of Paris (Groupe hospitalier Paris Saint-Joseph), 185 Rue Raymond Losserand, 75014, Paris, France. FAU - Culine, Stephane AU - Culine S AD - Medical Oncology Department, University Hospital of Paris (Saint-Louis Hospital), 1 avenue Claude Vellefaux, 75010, Paris, France. AD - Paris Diderot University, 16 rue Huchard, 75018, Paris, France. FAU - Dubray, Bernard AU - Dubray B AD - Radiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, F-76 000, Rouen, France. AD - EA4108 QuantIf Litis, University of Rouen, 22 boulevard Gambetta, 76000, Rouen, France. FAU - Bonnet, Naima AU - Bonnet N AD - Unicancer, 101, rue de Tolbiac, F-75654, Paris, France. FAU - Asselain, Bernard AU - Asselain B AD - Unicancer, 101, rue de Tolbiac, F-75654, Paris, France. FAU - Salleron, Julia AU - Salleron J AD - Biostatistics Department, Institut de Cancerologie de Lorraine - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, F-54519, Vandoeuvre-les-Nancy, France. FAU - Faivre, Jean-Christophe AU - Faivre JC AUID- ORCID: 0000-0002-2617-3562 AD - Academic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandoeuvre-les-Nancy, France. LA - eng SI - ClinicalTrials.gov/NCT03143322 GR - PHRC K 15 149/Ministere des Finances et des Comptes Publics/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20210204 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 SB - IM MH - Adult MH - Bone Neoplasms/secondary/*surgery/therapy MH - Breast Neoplasms/pathology/*surgery/therapy MH - Carcinoma, Non-Small-Cell Lung/pathology/*surgery/therapy MH - Clinical Trials, Phase III as Topic MH - Combined Modality Therapy MH - Female MH - Follow-Up Studies MH - Humans MH - Lung Neoplasms/pathology/*surgery/therapy MH - Male MH - Multicenter Studies as Topic MH - Prognosis MH - Prostatic Neoplasms/pathology/*surgery/therapy MH - Radiosurgery/*methods MH - Randomized Controlled Trials as Topic MH - Survival Rate PMC - PMC7863429 OTO - NOTNLM OT - Bone metastases OT - Breast neoplasms OT - Lung neoplasms OT - MeSH: Oligometastases OT - Neoplasm metastasis OT - Prostatic neoplasms OT - Radiosurgery OT - Stereotactic radiotherapy COIS- The authors declare that they have no competing interests. EDAT- 2021/02/06 06:00 MHDA- 2021/05/11 06:00 PMCR- 2021/02/04 CRDT- 2021/02/05 05:38 PHST- 2020/10/02 00:00 [received] PHST- 2021/01/21 00:00 [accepted] PHST- 2021/02/05 05:38 [entrez] PHST- 2021/02/06 06:00 [pubmed] PHST- 2021/05/11 06:00 [medline] PHST- 2021/02/04 00:00 [pmc-release] AID - 10.1186/s12885-021-07828-2 [pii] AID - 7828 [pii] AID - 10.1186/s12885-021-07828-2 [doi] PST - epublish SO - BMC Cancer. 2021 Feb 4;21(1):117. doi: 10.1186/s12885-021-07828-2.