Assessing Quality of Life and Outcomes for Cancer Patients Using RefleXion Radiotherapy
Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
This study is trying to see how different types of radiotherapy affect the quality of life and treatment outcomes for about 750 cancer patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | RefleXion Medical Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Duarte, California and 4 other locations) |
| Trial ID | NCT05406167 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical outcomes and quality of life for patients undergoing radiotherapy using the RefleXion Medical Radiotherapy System. It will enroll approximately 750 patients diagnosed with local, locoregionally advanced, or metastatic malignancies, who will receive intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT). The study will analyze the severity of adverse effects, patient costs, and the workflow of radiotherapy planning, collecting dosimetric data throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with local, locoregionally advanced, or metastatic malignancies who are indicated for radiotherapy.
Not a fit: Patients who are pregnant or have psychiatric or substance abuse disorders that interfere with study participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment outcomes and quality of life for cancer patients receiving advanced radiotherapy techniques.
How similar studies have performed: Other studies have shown success with similar radiotherapy approaches, indicating potential for meaningful advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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. * For BgRT patients only: Deemed eligible for BgRT with FDG per BgRT planning session 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. * For BgRT patients only: Known allergy to FDG
Where this trial is running
Duarte, California and 4 other locations
- City Of Hope — Duarte, California, United States (Recruiting)
- Stanford Cancer Center — Palo Alto, California, United States (Recruiting)
- Yale University - Cancer Center — New Haven, Connecticut, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- UT Southwestern — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Debradenise S. Brooks
- Email: dbrooks@reflexion.com
- Phone: 6504828435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.