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
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Condition or disease | Intervention/treatment |
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Cancer Cancer Central Nervous System Cancer Thoracic Cancer, Gastrointestinal Cancer Gynecologic Cancer, Genito-Urinary Cancers Lymphatic Cancer Head and Neck | Device: Registry - Observational |
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] |
Estimated Enrollment : | 500 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry) |
Actual Study Start Date : | April 12, 2022 |
Estimated Primary Completion Date : | April 25, 2026 |
Estimated Study Completion Date : | April 25, 2026 |
Group/Cohort | Intervention/treatment |
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Stereotactic Body Radiotherapy [SBRT]
Patients treated with Reflexion X1 with SBRT as the standard of care
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Device: Registry - Observational
Observation Registry for Medical Device
Other Name: Reflexion X1 |
Intensity -Modulated Radiation Therapy [IMRT]
Patients treated with Reflexion X1 with IMRT as the standard of care
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Device: Registry - Observational
Observation Registry for Medical Device
Other Name: Reflexion X1 |
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05406167
Contact: Debradenise Brooks | 6504828435 | dbrooks@reflexion.com | |
Contact: Didem Aksoy | daksoy@reflexion.com |
United States, California | |
City Of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Joan Marcia jmarcia@coh.org | |
Contact: Diamond Ward diward@coh.org | |
United States, Texas | |
UT Southwestern | Recruiting |
Dallas, Texas, United States, 75235 | |
Principal Investigator: Tu Dan, MD |
Study Director: | Sean Shirvani, MD | RefleXion Medical | |
Study Director: | Karine Feghali, MD | RefleXion Medical |
Responsible Party: | RefleXion Medical |
ClinicalTrials.gov Identifier: | NCT05406167 |
Other Study ID Numbers: |
985-00003 |
First Posted: | June 6, 2022 Key Record Dates |
Last Update Posted: | August 9, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
IMRT SBRT Radiation Oncology |
Gastrointestinal Neoplasms Urogenital Neoplasms Central Nervous System Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Nervous System Neoplasms Nervous System Diseases |