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).
Adult
Bone Neoplasms
/ secondary
Breast Neoplasms
/ pathology
Carcinoma, Non-Small-Cell Lung
/ pathology
Clinical Trials, Phase III as Topic
Combined Modality Therapy
Female
Follow-Up Studies
Humans
Lung Neoplasms
/ pathology
Male
Multicenter Studies as Topic
Prognosis
Prostatic Neoplasms
/ pathology
Radiosurgery
/ methods
Randomized Controlled Trials as Topic
Survival Rate
Bone metastases
Breast neoplasms
Lung neoplasms
MeSH: Oligometastases
Neoplasm metastasis
Prostatic neoplasms
Radiosurgery
Stereotactic radiotherapy
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
04 Feb 2021
04 Feb 2021
Historique:
received:
02
10
2020
accepted:
21
01
2021
entrez:
5
2
2021
pubmed:
6
2
2021
medline:
11
5
2021
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study.
Identifiants
pubmed: 33541288
doi: 10.1186/s12885-021-07828-2
pii: 10.1186/s12885-021-07828-2
pmc: PMC7863429
doi:
Banques de données
ClinicalTrials.gov
['NCT03143322']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
117Subventions
Organisme : Ministère des Finances et des Comptes Publics
ID : PHRC K 15 149
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