PREMIER: Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Study Details
Study Description
Brief 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), 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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N = 250 IMRT
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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:
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Central Nervous System (Brain, spinal cord, and vertebral column)
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Head and Neck
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Thoracic
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Gastrointestinal
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Gynecologic
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Genitourinary
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Lymphoma
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Melanoma/Sarcoma/Extremity
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Stereotactic Body Radiotherapy [SBRT] Patients treated with Reflexion X1 with SBRT as the standard of care |
Device: Registry - Observational
Observation Registry for Medical Device
Other Names:
|
| Intensity -Modulated Radiation Therapy [IMRT] Patients treated with Reflexion X1 with IMRT as the standard of care |
Device: Registry - Observational
Observation Registry for Medical Device
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Health Related Quality of Life (HRQOL) scores [30 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.
- Health Related Quality of Life (HRQOL) scores [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.
Secondary Outcome Measures
- Long Term Health-Related Quality of Life-EORTC [6 months, 9 months, 12 months, 18 months, and 24 months]
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.
- Long Term Health Related Quality of Life-EuroQol [6 months, 9 months, 12 months, 18 months, and 24 months]
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.
- Acute toxicities related to Radiotherapy treatment [Up to 90 days]
Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment
- Disease Status [progression-free survival] [Through Study Completion, average of 2 years]
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.
- Disease Status [local recurrence] [Through Study Completion, average of 2 years]
Evaluate local control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
- Disease Status [regional recurrence] [Through Study Completion, average of 2 years]
Evaluate regional control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
- Disease Status [distant recurrence] [Through Study Completion, average of 2 years]
Evaluate distant control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
- Disease Status [overall survival] [Through Study Completion, average of 2 years]
Evaluate overall survival after intensity modulated radiotherapy or stereotactic body radiotherapy for the cancers above.
- Intervention and Episodic costs [Up to 6 months]
Analyze resource utilization associated with the RefleXion system for the tumors above including the acute costs of intervention & 6-month episodic costs.
- Long-term toxicities related to Radiotherapy [After 90 days through study completion]
Analyze long term treatment toxicity for the anatomic site undergoing treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to comprehend and willing to sign an informed consent form (ICF).
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Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy is indicated
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Radiotherapy to be delivered on the RMRS X1 with IMRT or SBRT technique.
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Absence of concurrent illness that deems radiotherapy a contraindication which will be determined by the treating radiation oncologist.
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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:
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Pregnant or expecting to conceive during the study.
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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.
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Inability to maintain immobilization, supine position for planning and treatments.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City Of Hope | Duarte | California | United States | 91010 |
| 2 | UT Southwestern | Dallas | Texas | United States | 75235 |
Sponsors and Collaborators
- RefleXion Medical
Investigators
- Study Director: Sean Shirvani, MD, RefleXion Medical
- Study Director: Karine Feghali, MD, RefleXion Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 985-00003