CancerPREMIERNCT05406167
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
An observational study of Cancer and Cancer Central Nervous System, run by RefleXion Medical at 5 sites in United States.
Trial summary
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), or SCINTIX Biology-guided radiotherapy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Cancer Central Nervous System, Cancer Thoracic
- What is being tested?
- Registry - Observational
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Apr 2022to 25 Apr 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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), and Biology-guided radiotherapy (BgRT), in standard of care(SOC)use in the treatment of local, locoregionally advanced, and oligometastaticmalignancies. 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 collection of dosimetric data will also be analyzed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mario Esquivel contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
UT Southwestern
Dallas, Texas, 75235
Tu Dan, MD
- Recruiting
City Of Hope
Duarte, California, 91010
Arya Amini, MD
- Recruiting
Yale University - Cancer Center
New Haven, Connecticut, 06510
Henry Park, MD
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94305
Lucas K Vitzthum, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Neal McCall, MD
About this study
Official title: Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
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), or SCINTIX Biology-guided radiotherapy (BgRT) 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.
Read the detailed description
This multi-center prospective registry is designed to assess the efficacy of IMRT, SBRT, and BgRT delivered via the RMRS. The study will seek to enroll approximately 750 patients initially and then remain open to further patients beyond at the discretion of the study sponsor and participating institutions. The number of IMRT, SBRT, and BgRT patients expected to enroll for the initial period is as follows:
- N = 250 IMRT
- N - 250 SBRT
- N - 250 BgRT
Patients diagnosed with local, locoregionally advanced, or metastatic malignancies will be treated with IMRT, SBRT, or BgRT 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, SBRT, and BgRT. 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 sub-stratum 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 2 years following their therapy. Other long-term follow-ups will capture data including standard of care (per physician's discretion) laboratory evaluation, quality of life questionnaires, performance status, routine radiographic assessments, physical exams, etc. (see Appendix B. Schedule of Events).
- Conditions
- Cancer, Cancer Central Nervous System, Cancer Thoracic, Cancer, Gastrointestinal, Cancer Gynecologic, Cancer, Genito-Urinary
- Being tested
- Registry - Observational
- Keywords
- IMRT, SBRT, Radiation Oncology
- Medical subject headings
- Neoplasms, Central Nervous System Neoplasms, Gastrointestinal Neoplasms, Urogenital Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry - ObservationalDevice
Also called Reflexion X1
Observation Registry for Medical Device
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy [SBRT] | Patients treated with Reflexion X1 with SBRT as the standard of care Receives: Device: Registry - Observational | |
| Intensity -Modulated Radiation Therapy [IMRT] | Patients treated with Reflexion X1 with IMRT as the standard of care Receives: Device: Registry - Observational | |
| Biology-guided Radiotherapy [BgRT] | Patients treated with Reflexion X1 with BgRT as the standard of care Receives: Device: Registry - Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (HRQOL) scores
Evaluate patient-reported quality of life after IMRT, SBRT, or BgRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30.
The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Measured: 30 Days
Health Related Quality of Life (HRQOL) scores
Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30.
The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Measured: 90 Days
Secondary outcomes (10)
Long Term Health-Related Quality of Life-EORTC
Long-term Health-Related Quality of Life (HRQOL) scores, including the EORTC QLQ-C30 at 6 months, 9 months, 12 months, 18 months, and 24 months.
The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Measured: 6 months, 9 months, 12 months, 18 months, and 24 months
Long Term Health Related Quality of Life-EuroQol
The EuroQOL-5D-FL (EQ-5D) will be used in parallel with the Health-Related Quality of Life (HRQOL) surveys to measure quality-adjusted life years.
The EQ-5D comprises five questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: 6 months, 9 months, 12 months, 18 months, and 24 months
Acute toxicities related to Radiotherapy treatment
Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment
Measured: Up to 90 days
Disease Status [progression-free survival]
Evaluate progression-free survival after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above. For prostate cancer cohort, biochemical progression-free survival will also be measured.
Measured: Through Study Completion, average of 2 years
Disease Status [local recurrence]
Evaluate local control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
Measured: Through Study Completion, average of 2 years
Disease Status [regional recurrence]
Evaluate regional control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
Measured: Through Study Completion, average of 2 years
Disease Status [distant recurrence]
Evaluate distant control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
Measured: Through Study Completion, average of 2 years
Disease Status [overall survival]
Evaluate overall survival after intensity modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
Measured: Through Study Completion, average of 2 years
Intervention and Episodic costs
Analyze resource utilization associated with the RefleXion system for the tumors above including the acute costs of intervention \& 6-month episodic costs.
Measured: Up to 6 months
Long-term toxicities related to Radiotherapy
Analyze long term treatment toxicity for the anatomic site undergoing treatment
Measured: After 90 days through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start12 Apr 2022
- Primary completion25 Apr 2026 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- RefleXion Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Shirvani, MD, Study director, RefleXion MedicalKarine Feghali, MD, Study director, RefleXion Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406167
- Sponsor's protocol ID
- 985-00003
- Acronym
- PREMIER
- Status last verified
- Aug 2025
- First submitted
- 2 May 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
- ClinicalTrials.gov ID
- NCT05406167
- Acronym / sponsor ID
- PREMIER / 985-00003
- Conditions
- Cancer, Cancer Central Nervous System, Cancer Thoracic, Cancer, Gastrointestinal, Cancer Gynecologic, Cancer, Genito-Urinary
- Keywords
- IMRT, SBRT, Radiation Oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RefleXion MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), or SCINTIX Biology-guided radiotherapy (BgRT) 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.
Detailed description
This multi-center prospective registry is designed to assess the efficacy of IMRT, SBRT, and BgRT delivered via the RMRS. The study will seek to enroll approximately 750 patients initially and then remain open to further patients beyond at the discretion of the study sponsor and participating institutions. The number of IMRT, SBRT, and BgRT patients expected to enroll for the initial period is as follows:
- N = 250 IMRT
- N - 250 SBRT
- N - 250 BgRT
Patients diagnosed with local, locoregionally advanced, or metastatic malignancies will be treated with IMRT, SBRT, or BgRT 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, SBRT, and BgRT. 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 sub-stratum 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 2 years following their therapy. Other long-term follow-ups will capture data including standard of care (per physician's discretion) laboratory evaluation, quality of life questionnaires, performance status, routine radiographic assessments, physical exams, etc. (see Appendix B. Schedule of Events).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy [SBRT] | – | Device: Registry - ObservationalPatients treated with Reflexion X1 with SBRT as the standard of care |
| Intensity -Modulated Radiation Therapy [IMRT] | – | Device: Registry - ObservationalPatients treated with Reflexion X1 with IMRT as the standard of care |
| Biology-guided Radiotherapy [BgRT] | – | Device: Registry - ObservationalPatients treated with Reflexion X1 with BgRT as the standard of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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), and Biology-guided radiotherapy (BgRT), in standard of care(SOC)use in the treatment of local, locoregionally advanced, and oligometastaticmalignancies. 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 collection of dosimetric data will also be analyzed.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registry - ObservationalAlso: Reflexion X1Observation Registry for Medical Device | Device | Biology-guided Radiotherapy [BgRT], Intensity -Modulated Radiation Therapy [IMRT], Stereotactic Body Radiotherapy [SBRT] |
Primary outcome
Health Related Quality of Life (HRQOL) scores
Time frame: 30 Days
Evaluate patient-reported quality of life after IMRT, SBRT, or BgRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
Health Related Quality of Life (HRQOL) scores
Time frame: 90 Days
Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30. The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.
10 secondary outcomes
Long Term Health-Related Quality of Life-EORTC
Time frame: 6 months, 9 months, 12 months, 18 months, and 24 months
Long Term Health Related Quality of Life-EuroQol
Time frame: 6 months, 9 months, 12 months, 18 months, and 24 months
Acute toxicities related to Radiotherapy treatment
Time frame: Up to 90 days
Disease Status [progression-free survival]
Time frame: Through Study Completion, average of 2 years
Disease Status [local recurrence]
Time frame: Through Study Completion, average of 2 years
Disease Status [regional recurrence]
Time frame: Through Study Completion, average of 2 years
Disease Status [distant recurrence]
Time frame: Through Study Completion, average of 2 years
Disease Status [overall survival]
Time frame: Through Study Completion, average of 2 years
Intervention and Episodic costs
Time frame: Up to 6 months
Long-term toxicities related to Radiotherapy
Time frame: After 90 days through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Esquivel contact
Sean Shirvani, MD study director
RefleXion Medical
Karine Feghali, MD study director
RefleXion Medical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer Central Nervous System, run by RefleXion Medical at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debradenise S. Brooks (6504828435, dbrooks@reflexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (HRQOL) scores (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.