Stereotactic ablative radiotherapy for the comprehensive treatment of 1–3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial

Background A recent randomized phase II trial evaluated stereotactic ablative radiotherapy (SABR) in a group of patients with a small burden of oligometastatic disease (mostly with 1–3 metastatic lesions), and found that SABR was associated with a significant improvement in progression-free survival...

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Vydáno v:	BMC cancer Ročník 20; číslo 1; s. 380 - 12
Hlavní autoři:	Olson, Robert, Mathews, Lindsay, Liu, Mitchell, Schellenberg, Devin, Mou, Benjamin, Berrang, Tanya, Harrow, Stephen, Correa, Rohann J. M., Bhat, Vasudeva, Pai, Howard, Mohamed, Islam, Miller, Stacy, Schneiders, Famke, Laba, Joanna, Wilke, Derek, Senthi, Sashendra, Louie, Alexander V., Swaminath, Anand, Chalmers, Anthony, Gaede, Stewart, Warner, Andrew, de Gruijl, Tanja D., Allan, Alison, Palma, David A.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	London BioMed Central 05.05.2020 BioMed Central Ltd Springer Nature B.V BMC
Témata:	Abdomen Adult Aged Aged, 80 and over Antigens Biomedical and Life Sciences Biomedicine Biopsy Breast Cancer Cancer metastasis Cancer Research Cancer therapies Care and treatment Chemotherapy Clinical trials Clinical Trials, Phase III as Topic Disease Progression Dose Fractionation, Radiation Female Four-Dimensional Computed Tomography - methods Health Promotion and Disease Prevention Histology Humans Lesions Male Medical and radiation oncology Medicine/Public Health Metastases Metastasis Middle Aged Multicenter Studies as Topic Neoplasm Metastasis Neoplasms - pathology Neoplasms - surgery Neoplastic Cells, Circulating - pathology Oligometastases Oncology Patient Selection Patients Prostate Quality of Life Radiation therapy Radiosurgery - methods Radiotherapy Randomized Controlled Trials as Topic Spinal cord Stereotactic radiotherapy Study Protocol Surgical Oncology Survival Survival Rate Toxicity Treatment Outcome Tumor cells Tumors Young Adult Oligometastases Survival Stereotactic radiotherapy Quality of life Cancer
ISSN:	1471-2407, 1471-2407
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Shrnutí:	Background A recent randomized phase II trial evaluated stereotactic ablative radiotherapy (SABR) in a group of patients with a small burden of oligometastatic disease (mostly with 1–3 metastatic lesions), and found that SABR was associated with a significant improvement in progression-free survival and a trend to an overall survival benefit, supporting progression to phase III randomized trials. Methods Two hundred and ninety-seven patients will be randomized in a 1:2 ratio between the control arm (consisting of standard of care [SOC] palliative-intent treatments), and the SABR arm (consisting of SOC treatment + SABR to all sites of known disease). Randomization will be stratified by two factors: histology (prostate, breast, or renal vs. all others), and disease-free interval (defined as time from diagnosis of primary tumor until first detection of the metastases being treated on this trial; divided as ≤2 vs. > 2 years). The primary endpoint is overall survival, and secondary endpoints include progression-free survival, cost effectiveness, time to development of new metastatic lesions, quality of life (QoL), and toxicity. Translational endpoints include assessment of circulating tumor cells, cell-free DNA, and tumor tissue as prognostic and predictive markers, including assessment of immunological predictors of response and long-term survival. Discussion This study will provide an assessment of the impact of SABR on survival, QoL, and cost effectiveness to determine if long-term survival can be achieved for selected patients with 1–3 oligometastatic lesions. Trial registration Clinicaltrials.gov identifier: NCT03862911 . Date of registration: March 5, 2019,
Bibliografie:	ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Undefined-1 content type line 23
ISSN:	1471-2407 1471-2407
DOI:	10.1186/s12885-020-06876-4