MR-guided adaptive stereotactic radiotherapy for endometrial cancer, Radboud University
Summary
The National Library of Medicine registered a new clinical trial (NCT07514325) on ClinicalTrials.gov studying MR-guided adaptive stereotactic radiotherapy for endometrial cancer. The single-arm study will enroll an estimated 20 participants at Radboud University Medical Center in the Netherlands to evaluate feasibility and toxicity outcomes of adaptive radiotherapy guided by MRI imaging.
What changed
ClinicalTrials.gov published a new interventional study registration for a Phase 2 single-arm trial evaluating MR-guided adaptive stereotactic radiotherapy in patients with endometrial cancer after surgery. The study will assess feasibility, acute and late toxicity, and quality of life outcomes at Radboud University Medical Center. Estimated enrollment is 20 participants with completion expected in 2026.
For affected parties including clinical investigators and research coordinators, this registration establishes public accountability requirements under FDAAA 801. Sponsors must update trial status within 30 days of any change and submit results within 12 months of primary completion. Research institutions conducting oncology radiotherapy trials should ensure compliance with ClinicalTrials.gov registration and reporting timelines to avoid civil monetary penalties.
What to do next
- Ensure IRB/IEC approval and Good Clinical Practice compliance
- Register on ClinicalTrials.gov before enrolling participants under FDAAA 801 requirements
- Maintain accurate trial status updates including enrollment numbers and outcome data
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