Clinical Trial Finder

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.

This is a multi-center prospective registry designed to assess the efficacy of IMRT and SBRT delivered via the RMRS. The study will seek to enroll approximately 500 patients initially and then remain open to further patients beyond at the discretion of the study sponsor and participating institutions. The number of IMRTandSBRT patients expected to enroll for the initial period is as follows:

• - N = 250 IMRT.

• - N = 250 SBRT.

Patients diagnosed with local, locoregionally advanced, or metastatic malignancies will be treated with IMRT or SBRT using the RMRS, with total dose, fractionation, and concurrent systemic therapy delivered according to the direction of the radiation oncology care team. The target population is patients for whom standard radiotherapy is prescribed using IMRT or SBRT. Data will be stratified by common radiotherapy divisions as follows:

• - Central Nervous System (Brain, spinal cord, and vertebral column) - Head and Neck.

• - Thoracic.

• - Gastrointestinal.

• - Gynecologic.

• - Genitourinary.

• - Lymphoma.

• - Melanoma/Sarcoma/Extremity.

• - Non-Spine Bone and Other An additional substratum within each anatomic division will specify whether the treatment intent is for definitive treatment of the primary tumor (for early-stage or locally advanced disease), a definitive oligo/polymetastatic therapy, or a palliative therapy.

Patients will be routinely assessed during their radiation course and thereafter for toxicity burden and HRQOL using the CTCAE v5, EORTC, and EuroQOL surveys. Patients will be assessed for 2years following their therapy. Other long-term follow-ups will capture data including routine laboratory evaluation, quality of life questionnaires, performance status, routine radiographic assessments, physical exams, etc.

Arms

: Stereotactic Body Radiotherapy [SBRT]

Patients treated with Reflexion X1 with SBRT as the standard of care

: Intensity -Modulated Radiation Therapy [IMRT]

Patients treated with Reflexion X1 with IMRT as the standard of care

Interventions

Device: - Registry - Observational

Observation Registry for Medical Device