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

Launched by REFLEXION MEDICAL · May 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well a new radiotherapy system, called the RefleXion Medical Radiotherapy System, works for patients with various types of cancer. The researchers want to learn about the effectiveness of different radiotherapy techniques used with this system, including intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), and a special method called biology-guided radiotherapy (BgRT). They will also examine how these treatments affect patients' quality of life, any side effects they may experience, and the costs associated with their care.

Eligible participants for the study are adults diagnosed with certain types of advanced or metastatic cancers who need radiotherapy. They must be able to understand and sign a consent form, and be willing to take precautions to avoid pregnancy during treatment. Throughout the trial, participants will receive the radiotherapy treatment and will be monitored for any side effects and improvements in their health. This study is actively recruiting patients and aims to gather important information to help improve cancer treatment in the future.

Gender

ALL

Eligibility criteria

• 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