Evidence map›Paper›PMID 33541288›Full record

ArticleBMC cancer2021

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).

Sébastien Thureau, Vincent Marchesi, Marie-Hélène Vieillard, Lionel Perrier, Albert Lisbona, Marianne Leheurteur, Jean Tredaniel, Stéphane Culine, Bernard Dubray, Naïma Bonnet and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03143322 (Extracranial Stereotactic Body Radiation Therapy), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03143322 naactive not recruitingnot on this map

Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases

TypeinterventionalSponsorUNICANCERRan2018 to 2027Enrolled168ConditionsMetastatic Breast Cancer, Metastatic Lung Cancer, Metastatic Prostate Cancer, Bone MetastasesArmsSBRT
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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  15. Locoregional treatment ofFrontiers in oncology · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Sébastien ThureauRadiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, F-76 000, Rouen, France. sebastien.thureau@chb.unicancer.fr.
Vincent MarchesiAcademic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandœuvre-lès-Nancy, France.
Marie-Hélène VieillardRheumatology Department, University Hospital of Lille, 2 avenue Oscar Lambret, 59 000, Lille, France.
Lionel PerrierUMR CNRS 5824, Léon Bérard Comprehensive Cancer Center, 28 rue laennec, 69 373, Lyon, France.
Albert LisbonaAcademic Radiation Oncology & Brachytherapy Department, Institut de Cancérologie de l'Ouest - René Gauducheau Comprehensive Cancer Center, Boulevard Professeur Jacques Monod, 44805, Saint-Herblain, France.
Marianne LeheurteurMedical Oncology Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, 76000, Rouen, France.
Jean TredanielPneumology Department, University Hospital of Paris (Groupe hospitalier Paris Saint-Joseph), 185 Rue Raymond Losserand, 75014, Paris, France.
Stéphane CulineMedical Oncology Department, University Hospital of Paris (Saint-Louis Hospital), 1 avenue Claude Vellefaux, 75010, Paris, France.
Bernard DubrayRadiation Oncology & Medical Physics Department, Henri-Becquerel Comprehensive Cancer Center, rue d'Amiens, F-76 000, Rouen, France.
Naïma BonnetUnicancer, 101, rue de Tolbiac, F-75654, Paris, France.
Bernard AsselainUnicancer, 101, rue de Tolbiac, F-75654, Paris, France.
Julia SalleronBiostatistics Department, Institut de Cancérologie de Lorraine - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, F-54519, Vandœuvre-lès-Nancy, France.
Jean-Christophe FaivreAcademic Radiation Oncology & Brachytherapy Department, Lorraine Institute of Cancerology - Alexis-Vautrin Comprehensive Cancer Center, 6 avenue de Bourgogne, 54519, Vandœuvre-lès-Nancy, France.ORCID http://orcid.org/0000-0002-2617-3562
Institut de Cancérologie de Lorraine · FRUniCancer Group · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre National de la Recherche Scientifique · FRCentre Oscar Lambret · FRDélégation Paris 7 · FRHôpital Paris Saint-Joseph · FRInstitut de Cancérologie de l'Ouest · FRLaboratoire d'Informatique, du Traitement de l'Information et des Systèmes · FR

Funding

Ministère des Finances et des Comptes Publics PHRC K 15 149
6 · The paper itself

Abstract

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. 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.

Indexed as

AdultBone NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungClinical Trials, Phase III as TopicCombined Modality TherapyEquivalence Trials as TopicFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMulticenter Studies as TopicPrognosisProstatic NeoplasmsRadiosurgeryBone metastasesBreast neoplasmsLung neoplasmsMeSH: OligometastasesNeoplasm metastasisProstatic neoplasmsRadiosurgeryStereotactic radiotherapy

Identifiers

PMID33541288
PMCPMC7863429
OpenAlexW3127246138

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.