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Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER)

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ClinicalTrials.gov Identifier: NCT05406167
Recruitment Status : Recruiting
First Posted : June 6, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
RefleXion Medical

Tracking Information
First Submitted Date May 2, 2022
First Posted Date June 6, 2022
Last Update Posted Date August 9, 2022
Actual Study Start Date April 12, 2022
Estimated Primary Completion Date April 25, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2022)
  • Health Related Quality of Life (HRQOL) scores [ Time Frame: 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 [ 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.
Original Primary Outcome Measures
 (submitted: May 31, 2022)
  • Health Related Quality of Life (HRQOL) scores [ Time Frame: 30 Days ]
    Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30.
  • 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.
Change History
Current Secondary Outcome Measures
 (submitted: May 31, 2022)
  • 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 (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 [ Time Frame: 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 [ Time Frame: Up to 90 days ]
    Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment
  • Disease Status [progression-free survival] [ Time Frame: 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] [ Time Frame: 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] [ Time Frame: 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] [ Time Frame: 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] [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 90 days through study completion ]
    Analyze long term treatment toxicity for the anatomic site undergoing treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
Official Title Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)
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.
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:

  • 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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), 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.
Condition
  • Cancer
  • Cancer Central Nervous System
  • Cancer Thoracic
  • Cancer, Gastrointestinal
  • Cancer Gynecologic
  • Cancer, Genito-Urinary
  • Cancers Lymphatic
  • Cancer Head and Neck
Intervention Device: Registry - Observational
Observation Registry for Medical Device
Other Name: Reflexion X1
Study Groups/Cohorts
  • Stereotactic Body Radiotherapy [SBRT]
    Patients treated with Reflexion X1 with SBRT as the standard of care
    Intervention: Device: Registry - Observational
  • Intensity -Modulated Radiation Therapy [IMRT]
    Patients treated with Reflexion X1 with IMRT as the standard of care
    Intervention: Device: Registry - Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 31, 2022)		 500
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 25, 2026
Estimated Primary Completion Date April 25, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Debradenise Brooks 6504828435 dbrooks@reflexion.com
Contact: Didem Aksoy daksoy@reflexion.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05406167
Other Study ID Numbers 985-00003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party RefleXion Medical
Original Responsible Party Same as current
Current Study Sponsor RefleXion Medical
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Sean Shirvani, MD RefleXion Medical
Study Director: Karine Feghali, MD RefleXion Medical
PRS Account RefleXion Medical
Verification Date May 2022