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NCT05703269 · ClinicalTrials.gov registry record · NA
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy
A NA study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT05703269: Recruiting NA study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Wake Forest University Health Sciences.
NCT05703269 is a NA study of Non-Small Cell Lung Cancer and Melanoma that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 244 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05703269, a NA study of Non-Small Cell Lung Cancer and Melanoma, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to see if we can lower the chance of side effects from radiation in patients with breast, kidney, small cell lung cancer, non-small cell lung cancer or melanoma that has spread to the brain and who are also being treated with immunotherapy, specifically immune checkpoint inhibitor (ICI) therapy. This study will compare the usual care treatment of single fraction stereotactic radiosurgery (SSRS) given on one day versus fractionated stereotactic radiosurgery (FSRS), which is a lower dose of radiation given over a few days to determine if FSRS is better or worse at reducing side effects than usual care treatment.
Primary Outcome
To compare the proportion of participants experiencing Grade 2 or higher Adverse Radiation Effects (ARE) within 9 months following randomization to single fraction stereotactic radiosurgery (SSRS) vs fractionated stereotactic radiosurgery (FSRS) in patients with brain metastases ≥ 2 cm in diameter or ≥ 4cc in volume treated with concurrent immune checkpoint inhibitor (ICI) therapy.
Conditions Studied
Interventions
- RADIATION single fraction stereotactic radiosurgery (SSRS)
- RADIATION fractionated stereotactic radiosurgery (FSRS)
Study Locations (20)
Michigan
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor - Ann Arbor
- Trinity Health IHA Medical Group Hematology Oncology - Brighton - Brighton
- Genesys Hurley Cancer Institute - Flint
- Trinity Health Saint Mary Mercy Livonia Hospital - Livonia
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus - Ypsilanti
Illinois
- Decatur Memorial Hospital - Decatur
- Crossroads Cancer Center - Effingham
- HSHS Saint Elizabeth's Hospital - O'Fallon
- OSF Saint Francis Medical Center - Peoria
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Missouri
- Mercy Hospital Springfield - Springfield
- Mercy Hospital South - St Louis
New Mexico
- Lovelace Medical Center-Saint Joseph Square - Albuquerque
- Lovelace Radiation Oncology - Albuquerque
North Carolina
- Carolinas Medical Center/Levine Cancer Institute - Charlotte
- Atrium Health Cabarrus/LCI-Concord - Concord
Georgia
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler - Savannah
New Jersey
- Overlook Medical Center - Summit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
What NCT05703269 shows while recruiting
NCT05703269 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (63% lower).
The record links to 8 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which single fraction stereotactic radiosurgery (SSRS) is the first listed.
NCT05703269 names 20 study sites across 8 states, led by Michigan, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT05703269 about?
NCT05703269 is a clinical study titled "Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy". This study is designed to see if we can lower the chance of side effects from radiation in patients with breast, kidney, small cell lung cancer, non-small cell lung cancer or melanoma that has spread to the brain and who are also being treated with immunotherapy, specifically immune checkpoint inhib...
What is the current status of trial NCT05703269?
This trial is currently recruiting. It is a NA study. The enrollment target is 244 participants. The study started on 2023-07-11. Estimated completion is 2028-03-31.
What conditions does trial NCT05703269 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma, Breast Carcinoma, Small-cell Lung Cancer.
What interventions are being tested in trial NCT05703269?
The interventions under investigation include: single fraction stereotactic radiosurgery (SSRS) (RADIATION), fractionated stereotactic radiosurgery (FSRS) (RADIATION).
Who is sponsoring clinical trial NCT05703269?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05703269 being conducted?
This trial has 20 study locations across Georgia, Illinois, Michigan, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05703269's enrollment target sits among peer trials
244 150th of 454 higher than 305 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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