The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.
Able to comprehend and be willing to sign an informed consent form (ICF).
Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
Radiotherapy to be delivered on the RMRS X1 with IMRT, SBRT, or BgRT technique.
Absence of concurrent illness that deems radiotherapy a contraindication which will be determined by the treating radiation oncologist.
Pregnant or expecting to conceive during the study.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with study requirements and follow-up visits.
Inability to maintain immobilization, supine position for planning and treatments.
For BgRT patients only: Known allergy to FDG
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), and Biology-guided radiotherapy (BgRT), in standard of care(SOC)use in the treatment of local, locoregionally advanced, and oligometastaticmalignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including collection of dosimetric data will also be analyzed.
Other
Prospective
Registry - Observational
DeviceObservation Registry for Medical Device
Health Related Quality of Life (HRQOL) scores
Evaluate patient-reported quality of life after IMRT, SBRT, or BgRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Health Related Quality of Life (HRQOL) scores
Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Long Term Health-Related Quality of Life-EORTC
Long-term Health-Related Quality of Life (HRQOL) scores, including the EORTC QLQ-C30 at 6 months, 9 months, 12 months, 18 months, and 24 months. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Long Term Health Related Quality of Life-EuroQol
The EuroQOL-5D-FL (EQ-5D) will be used in parallel with the Health-Related Quality of Life (HRQOL) surveys to measure quality-adjusted life years. The EQ-5D comprises five questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Acute toxicities related to Radiotherapy treatment
Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment
Disease Status [progression-free survival]
Evaluate progression-free survival after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above. For prostate cancer cohort, biochemical progression-free survival will also be measured.
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