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

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), 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cancer, Gastrointestinal; Cancer Central Nervous System; Cancer Thoracic; Cancer Gynecologic; Cancer, Genito-Urinary; Cancers Lymphatic; Cancer Head and Neck
• Intervention / Treatment: Device: Registry - Observational

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
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Debradenise Brooks; Phone Number: 6504828435; Email: dbrooks@reflexion.com
• Study Contact Backup: Name: Didem Aksoy; Email: daksoy@reflexion.com

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Contact: Joan Marcia; Email: jmarcia@coh.org
      • Contact: Diamond Ward; Email: diward@coh.org
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • UT Southwestern
      • Principal Investigator: Tu Dan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Reflexion X1
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: Reflexion X1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	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.	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.	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.	Up to 6 months
Long-term toxicities related to Radiotherapy	Analyze long term treatment toxicity for the anatomic site undergoing treatment	After 90 days through study completion

Collaborators and Investigators

• Sponsor: RefleXion Medical
• Investigators: Study Director: Sean Shirvani, MD, RefleXion Medical; Study Director: Karine Feghali, MD, RefleXion Medical

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Anticipated): April 25, 2026
• Study Completion (Anticipated): April 25, 2026

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: IMRT; SBRT; Radiation Oncology
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Nervous System Neoplasms; Gastrointestinal Neoplasms; Central Nervous System Neoplasms; Urogenital Neoplasms
• Other Study ID Numbers: 985-00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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