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Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Trial ID: NCT05406167
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), 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.
Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
- Able to comprehend and 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 or SBRT technique.
- Absence of concurrent illness that deems radiotherapy a contraindication which will be
determined by the treating radiation oncologist.
- Female and male patients of child-bearing potential willing to take appropriate
precautions to avoid pregnancy while being treated. Permitted methods in preventing
pregnancy should be communicated to the patient and their understanding confirmed by
the treating Physician.
- 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.
device: Registry - Observational