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NCT05419518 · ClinicalTrials.gov registry record · Phase 2
Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas
A Phase 2 study of Metastases, Neoplasm and Neoplasm Metastases, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 7
- Study locations
NCT05419518: Recruiting Phase 2 study of Metastases, Neoplasm and Neoplasm Metastases, sponsored by Rutgers, The State University of New Jersey.
NCT05419518 is a Phase 2 study of Metastases, Neoplasm and Neoplasm Metastases that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05419518, a Phase 2 study of Metastases, Neoplasm and Neoplasm Metastases, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 7
- Study locations
Study Summary
The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated biologically equivalent dose (BED) will result in a higher proportion of participants responding to treatment, and will also lead to more durable responses. Furthermore, the investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 35-45% in painful non-bone metastases
Primary Outcome
Number of participants experiencing adverse effects grade three or higher, as defined by Common Terminology Criteria for Adverse Effects version 5.0 (CTCAE v5.0)
Conditions Studied
Interventions
- BIOLOGICAL EXTERNAL BEAM RADIATION
Study Locations (7)
New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital - Hamilton
- RWJBarnabas Health - Monmouth Medical Center Southern Campus - Lakewood
- RWJBarnabas Health - Saint Barnabas Medical Center - Livingston
- Robert Wood Johnson University Hospital - New Brunswick
- Cancer Institute of New Jersey - New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospital - Somerset
- RWJBarnabas Health - Community Medical Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
What NCT05419518 shows while recruiting
NCT05419518 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 2 conditions, with Metastases, Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which EXTERNAL BEAM RADIATION is the first listed.
NCT05419518 lists 7 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT05419518 about?
NCT05419518 is a clinical study titled "Palliative Dose Escalated Radiation for Painful Non-Spine Bone Metastases and Painful Non-Bone Metas". The investigators hypothesize that with dose escalation to 40-50 Gy in ten fractions, the complete pain response rate at one month can be increased to 40-50% in painful non-spinal bone metastases. Additionally, the investigators hypothesize that utilizing a fractionation scheme with an escalated bio...
What is the current status of trial NCT05419518?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2023-03-16. Estimated completion is 2027-04-01.
What conditions does trial NCT05419518 study?
This clinical trial studies the following conditions: Metastases, Neoplasm, Neoplasm Metastases.
What interventions are being tested in trial NCT05419518?
The interventions under investigation include: EXTERNAL BEAM RADIATION (BIOLOGICAL).
Who is sponsoring clinical trial NCT05419518?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05419518 being conducted?
This trial has 7 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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