Neoplasms

Nervous System Diseases

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Central Nervous System Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Nervous System Neoplasms

Gastrointestinal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Quality of Life

Patients treated with Reflexion X1 with SBRT as the standard of care

Patients treated with Reflexion X1 with IMRT as the standard of care

Registry - Observational

Debradenise Brooks

Didem Aksoy

Joan Marcia

Diamond Ward

Tu Dan, MD

Sean Shirvani, MD

Karine Feghali, MD

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.

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.

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

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

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.

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.

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.

Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment

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.

Evaluate local control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Evaluate regional control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Evaluate distant control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Evaluate overall survival after intensity modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Analyze resource utilization associated with the RefleXion system for the tumors above including the acute costs of intervention \& 6-month episodic costs.

Analyze long term treatment toxicity for the anatomic site undergoing treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	NCT05406167	Cancer Cancer Central ... Cancer Thoracic Cancer, Gastroi... Cancer Gynecolo... Cancer, Genito-... Cancers Lymphat... Cancer Head and...	Registry - Obse...	-	RefleXion Medical
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	NCT05406167	Cancer Cancer Central ... Cancer Thoracic Cancer, Gastroi... Cancer Gynecolo... Cancer, Genito-... Cancers Lymphat... Cancer Head and...	Registry - Obse...	-	RefleXion Medical
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	NCT05406167	Cancer Cancer Central ... Cancer Thoracic Cancer, Gastroi... Cancer Gynecolo... Cancer, Genito-... Cancers Lymphat... Cancer Head and...	Registry - Obse...	-	RefleXion Medical

Spots Global Cancer Trial Database for cancer central nervous system