Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT07062003
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Histologically confirmed malignancy
* Primary, recurrent, or metastatic skin or superficial soft tissue tumor amenable to palliative orthovoltage radiotherapy
* Anticipated life expectancy ≥ 30 days and anticipated capacity for follow up for ≥ 30 days
* Negative pregnancy test done ≤ 28 days prior to registration, for biological women of childbearing potential only
* Willing to provide written informed consent
* Willing to allow baseline and follow up photograph acquisition for response and toxicity assessment
* Willing and able to return to enrolling institution for follow-up during the active monitoring phase of the study
* Willing to provide blood and tissue samples for correlative research purposes
Exclusion Criteria:
* Hematologic, germ cell, or any other tumor that the investigational team would deem to have a high likelihood of clinical complete response with standard palliative radiotherapy (8 Gy in 1, 30 Gy in 10, etc.)
* COHORT A (INTACT SKIN) ONLY: Prior radiotherapy targeting the lesion presenting for treatment or prior adjacent radiotherapy if \> 10 Gy overlaps with a portion of the planned target
* Treatment with a B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor, monoclonal antibodies targeting vascular endothelial growth factor (VEGF) (bevacizumab or ramucirumab) or small molecule inhibitors inhibiting VEGF within the last 2 weeks or planned treatment with BRAF inhibitor within 4 weeks after radiation
* Treatment with an investigational drug therapy within 2 weeks prior to or 4 weeks (the DLT monitoring period) after MBRT
* Any tumor with direct extension into the spine such that targeting the spine/spinal cord could not be avoided
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07062003
Study Brief:
Protocol Section:
NCT07062003