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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Published in:BMC cancer Vol. 20; no. 1; pp. 380 - 12
Main Authors: 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.
Format: Journal Article
Language:English
Published: London BioMed Central 05.05.2020
BioMed Central Ltd
Springer Nature B.V
BMC
Subjects:
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
Online Access:Get full text
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Summary: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,
Bibliography:ObjectType-Article-2
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ISSN:1471-2407
1471-2407
DOI:10.1186/s12885-020-06876-4