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

Cancer Clinical Trial

— PREMIER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406167
• Other study ID #: 985-00003
• Status: Recruiting
• Start date: April 12, 2022
• Est. completion date: April 25, 2026

Study information

• Verified date: May 2022
• Source: RefleXion Medical
• Contact: Debradenise Brooks
• Phone: 6504828435
• Email: dbrooks[@]reflexion.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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), 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 25, 2026
• Est. primary completion date: April 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cancer, Gastrointestinal
• Central Nervous System Neoplasms
• Gastrointestinal Neoplasms
• Urogenital Neoplasms

Intervention

Device:
• Registry - Observational
Observation Registry for Medical Device

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas
United States	City Of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
RefleXion Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Acute toxicities related to Radiotherapy treatment	Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment	Up to 90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Long-term toxicities related to Radiotherapy	Analyze long term treatment toxicity for the anatomic site undergoing treatment	After 90 days through study completion