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

Last updated: July 24, 2024
Sponsor: RefleXion Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Ulcers

Stomach Cancer

Gastrointestinal Diseases And Disorders

Treatment

Registry - Observational

Clinical Study ID

NCT05406167
985-00003
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 whomradiotherapy 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 willbe determined by the treating radiation oncologist.

  • Female and male patients of child-bearing potential willing to take appropriateprecautions to avoid pregnancy while being treated. Permitted methods in preventingpregnancy should be communicated to the patient and their understanding confirmed bythe treating Physician.

  • For BgRT patients only: Deemed eligible for BgRT with FDG per BgRT planning session

Exclusion

Exclusion Criteria:

  • Pregnant or expecting to conceive during the study.

  • Has a known psychiatric or substance abuse disorder that would interfere with theparticipant'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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Registry - Observational
Phase:
Study Start date:
April 12, 2022
Estimated Completion Date:
April 25, 2026

Study 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).

Connect with a study center

  • City Of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Stanford Cancer Center

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Yale University - Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15219
    United States

    Active - Recruiting

  • UT Southwestern

    Dallas, Texas 75235
    United States

    Active - Recruiting

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