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)
| Autor: | Bernard Asselain, Sébastien Thureau, Marianne Leheurteur, Bernard Dubray, Stéphane Culine, Jean-Christophe Faivre, Naïma Bonnet, Vincent Marchesi, Julia Salleron, Marie-Hélène Vieillard, Jean Trédaniel, Albert Lisbona, Lionel Perrier |
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| Přispěvatelé: | Groupe d'analyse et de théorie économique (GATE Lyon Saint-Étienne), Centre National de la Recherche Scientifique (CNRS)-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université Lumière - Lyon 2 (UL2)-École normale supérieure - Lyon (ENS Lyon), Equipe Quantification en Imagerie Fonctionnelle (QuantIF-LITIS), Laboratoire d'Informatique, de Traitement de l'Information et des Systèmes (LITIS), Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Université Le Havre Normandie (ULH), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Normandie Université (NU), Groupe d'Analyse et de Théorie Economique Lyon - Saint-Etienne (GATE Lyon Saint-Étienne), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS) |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
0301 basic medicine MESH: Combined Modality Therapy Cancer Research MeSH: Oligometastases [SDV]Life Sciences [q-bio] medicine.medical_treatment Study Protocol MESH: Clinical Trials Phase III as Topic 0302 clinical medicine Lung neoplasms Surgical oncology Carcinoma Non-Small-Cell Lung MESH: Radiosurgery Stereotactic radiotherapy Clinical endpoint Multicenter Studies as Topic Randomized Controlled Trials as Topic Standard treatment Bone metastasis MESH: Follow-Up Studies Prognosis lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens MESH: Bone Neoplasms [SHS.ECO]Humanities and Social Sciences/Economics and Finance Combined Modality Therapy Primary tumor 3. Good health Survival Rate Oncology 030220 oncology & carcinogenesis Female Prostatic neoplasms Radiology Adult medicine.medical_specialty MESH: Survival Rate Neoplasm metastasis Bone Neoplasms Radiosurgery lcsh:RC254-282 MESH: Prognosis 03 medical and health sciences Genetics medicine Humans Lung cancer MESH: Humans business.industry Bone metastases Cancer MESH: Adult medicine.disease MESH: Male MESH: Lung Neoplasms MESH: Randomized Controlled Trials as Topic 030104 developmental biology Clinical Trials Phase III as Topic MESH: Prostatic Neoplasms MESH: Multicenter Studies as Topic Breast neoplasms business MESH: Female MESH: Breast Neoplasms MESH: Carcinoma Non-Small-Cell Lung Follow-Up Studies |
| Zdroj: | BMC Cancer BMC Cancer, BioMed Central, 2021, 21 (1), ⟨10.1186/s12885-021-07828-2⟩ BMC Cancer, BioMed Central, 2021, 21 (1), pp.117. ⟨10.1186/s12885-021-07828-2⟩ BMC Cancer, Vol 21, Iss 1, Pp 1-10 (2021) BMC Cancer, 2021, 21 (1), ⟨10.1186/s12885-021-07828-2⟩ |
| ISSN: | 1471-2407 |
| DOI: | 10.1186/s12885-021-07828-2⟩ |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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