adrenal metastases
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Have adrenal metastases, for which MR-guided SABR has been recommended following dis-cussions within a multi-disciplinary tumor board. 2. Be willing and able to provide written informed consent for the trial. 3. Be 18 years of age on day of signing informed consent.
Exclusion criteria
Exclusion criteria: 1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 30 days prior to the MR-guided SABR. 2. Has had prior chemotherapy, targeted small molecule therapy, or radiotherapy within 30 days prior to MR-guided SABR. 3. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 4. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement will not be excluded from the study. 5. Has an active infection requiring systemic therapy. 6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject*s participation for the full du-ration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 7. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: This hypothesis generating study aims to characterize the immunological effects of different well-tolerated risk-adapted SMART schedules. The primary study endpoints will be the immune responses in the peripheral blood. The endpoints will be assessed by examination liquid biopsies and FACS analysis on peripheral blood to detect immune modulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be local tumor control rates and correlation of measured immune parameters with PTV coverage and rates of tumor regression. | — |
Countries
Netherlands
Outcome results
None listed