Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System


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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.

Official Title

Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)

Stanford Investigator(s)

Lucas Kas Vitzthum, MD
Lucas Kas Vitzthum, MD

Clinical Associate Professor, Radiation Oncology - Radiation Therapy


Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Team rad-onc

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