Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases (SIM-FREE RT)

Utah System of Higher Education (USHE)

Status

Enrolling

Conditions

Bone Metastases

Treatments

Radiation: simulation-free, single-fraction palliative radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07202273

HCI193478

Details and patient eligibility

About

The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant aged ≥ 18 years.
Diagnosis of any cancer with one to two painful and treatable metastatic bone lesions.
Bone metastases are causing pain or instability in the opinion of the treating investigator.
Amenable to single fraction radiation therapy per the discretion of the treating physician.
CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
ECOG Performance Status ≤ 2.
Participants must adhere to the following sex and contraceptive/barrier requirements:
- If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy test are available for review before treatment.
- For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  - < 50 years of age:
    - Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
    - Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
      
      ---≥ 50 years of age:
    - Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
    - Had radiation-induced menopause with last menses >1 year ago; or
    - Had chemotherapy-induced menopause with last menses >1 year ago
  - Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion criteria

Evidence of spinal cord compression caused by the bone metastases to be treated.
Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Participants taking prohibited medications as described in Section 6.7.1.