Registry to assess adverse events from ablative radiotherapy in metastatic cancer
Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
Duke University · NCT04085029
This study is trying to collect information about side effects from a specific type of radiation treatment for adults with metastatic cancer to better understand how safe it is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 5 sites (Cary, North Carolina and 4 other locations) |
| Trial ID | NCT04085029 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry of patients undergoing ablative radiotherapy for metastatic disease. It focuses on collecting data to evaluate the rates of acute adverse events associated with this treatment approach. Participants must be at least 18 years old and have radiographic evidence of metastatic disease, with plans to receive or having received hypofractionated image-guided radiotherapy. The study will help in understanding the safety profile of this treatment modality in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented metastatic disease who are receiving or have received ablative radiotherapy.
Not a fit: Patients who do not have metastatic disease or are not receiving ablative radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and adverse effects of ablative radiotherapy, improving patient management and treatment decisions.
How similar studies have performed: While there have been studies on ablative radiotherapy, this registry approach to specifically assess acute adverse events is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years of age * Radiographic evidence of metastatic disease (may include oligoprogression, oligorecurrence or oligometastasis) at the time of study enrollment * Planned to receive, currently receiving, or have completed hypofractionated image guided radiotherapy (ablative radiotherapy) to an extracranial site(s) * Patient must sign study-specific informed consent Exclusion Criteria: • None
Where this trial is running
Cary, North Carolina and 4 other locations
- Duke Cancer Institute Cary — Cary, North Carolina, United States (RECRUITING)
- Durham Veterans Administration Health Care System (DVAHCS) — Durham, North Carolina, United States (RECRUITING)
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
- Duke Women's Cancer Care Raleigh — Raleigh, North Carolina, United States (RECRUITING)
- Duke Raleigh Hospital — Raleigh, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Joseph Salama, MD — Duke University
- Study coordinator: Clinical Trials Office
- Email: RadOnc-Clinical_Trials@dm.duke.edu
- Phone: (919) 668 3726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oligometastasis, Metastatic Cancer, Ablative radiotherapy