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

Recruiting

• Conditions: Cancer Thoracic; Cancers Lymphatic; Cancer, Gastrointestinal; Cancer, Genito-Urinary; Cancer Head and Neck; Cancer Central Nervous System; Cancer; Cancer Gynecologic
• Interventions: Device: Registry - Observational

• Registration Number: NCT05406167
• Lead Sponsor: RefleXion Medical

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), 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 Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2026-04-25
• Study Completion: 2026-04-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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

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.
• For BgRT patients only: Known allergy to FDG

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiotherapy [SBRT]	Registry - Observational	Patients treated with Reflexion X1 with SBRT as the standard of care
Intensity -Modulated Radiation Therapy [IMRT]	Registry - Observational	Patients treated with Reflexion X1 with IMRT as the standard of care
Biology-guided Radiotherapy [BgRT]	Registry - Observational	Patients treated with Reflexion X1 with BgRT as the standard of care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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 [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 [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.
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 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.
Long-term toxicities related to Radiotherapy	After 90 days through study completion	Analyze long term treatment toxicity for the anatomic site undergoing treatment

Trial Locations

Locations (5)

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

City Of Hope; 🇺🇸 Duarte, California, United States

Yale University - Cancer Center; 🇺🇸 New Haven, Connecticut, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UT Southwestern; 🇺🇸 Dallas, Texas, United States