Actively Recruiting
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
Led by RefleXion Medical · Updated on 2025-08-15
500
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the RefleXion Medical Radiotherapy System (RMRS) to deliver three types of radiation treatments: intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), and biology-guided radiotherapy (BgRT) for patients with local, loco-regionally advanced, or metastatic cancers. This prospective registry study aims to assess clinical outcomes, quality of life, and the severity of side effects from these treatments, while also analyzing patient costs and the quality of radiotherapy planning. The study involves multiple cancer types including central nervous system, head and neck, thoracic, gastrointestinal, gynecologic, genitourinary, lymphoma, and others. Participants will receive standard radiotherapy treatment using RMRS with the type of therapy (IMRT, SBRT, or BgRT) determined by the radiation oncology team. The study plans to enroll about 750 patients divided evenly among the three treatment methods. Treatment doses, schedules, and any additional systemic therapies will follow standard care practices. Patients will be assessed routinely during treatment and followed for up to two years to monitor side effects, quality of life, and disease status. During the study, participants will complete quality of life surveys and undergo regular assessments including toxicity evaluations, laboratory tests, physical exams, and imaging as part of their standard care. Data on health-related quality of life will be collected at multiple time points up to 24 months after treatment. Researchers will also track costs and charges associated with the treatments. This long-term follow-up will help understand both the clinical and economic impact of radiotherapy using the RMRS.
CONDITIONS
Brief Title
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign an informed consent form
- Diagnosed with local, loco-regionally advanced, or metastatic malignancy needing radiotherapy
- Planned radiotherapy to be delivered using the RefleXion Medical Radiotherapy System with IMRT, SBRT, or BgRT
- No other illnesses that make radiotherapy unsafe as determined by the radiation oncologist
- Female and male patients of child-bearing potential willing to use appropriate pregnancy prevention methods
- BgRT patients must be eligible for BgRT with FDG per planning session
You will not qualify if you...
- Pregnant or expecting to conceive during the study
- Known psychiatric or substance abuse disorder interfering with study participation or follow-up
- Unable to stay still in a supine position for planning and treatments
- BgRT patients with known allergy to FDG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies according to prescribed radiotherapy course
Participants receive radiotherapy treatment using the RefleXion Medical Radiotherapy System with IMRT, SBRT, or BgRT as part of their routine cancer care.
Participants are routinely assessed during their radiation course
Duration - Up to 2 years
Participants are followed for toxicity, quality of life, disease status, and other health outcomes for up to 2 years after their radiotherapy treatment.
Follow-up visits and assessments occur periodically up to 2 years
Trial Site Locations
Total: 5 locations
1
City Of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Stanford Cancer Center
Palo Alto, California, United States, 94305
Actively Recruiting
3
Yale University - Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
5
UT Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
D
Debradenise S. Brooks
M
Mario Esquivel
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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