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NCT02581384 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02581384: Clinical Trial Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT02581384 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581384, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.
Primary Outcome
Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLTs are defined as follows: Grade 2 or higher toxicities: * Myelitis * Esophageal fistula, perforation, hemorrhage Grade 3 or higher toxicities considered to be a direct result of therapy: * Pneumonitis * Pericarditis, pericardial effusion * Esophageal necrosis, stenosis, ulcer * Dyspnea Grade 4 toxicities
Interventions
- RADIATION Stereotactic Body Radiotherapy (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-01 |
| Est. Completion | 2020-08 |
| Phase | Phase 1 |
Why NCT02581384 stopped before completion
NCT02581384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Stereotactic Body Radiotherapy (SBRT) is the first listed.
NCT02581384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02581384 about?
NCT02581384 is a clinical study titled "Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors". This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of t...
What is the current status of trial NCT02581384?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2017-01. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02581384?
The interventions under investigation include: Stereotactic Body Radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT02581384?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02581384's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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