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NCT02582931 · ClinicalTrials.gov registry record · Phase 1
MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02582931 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 10 participants.
The verdict
NCT02582931, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treatment machine. To best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. The prescription dose will be determined based on hard normal tissue constraints, and capped at 10Gy per fraction. Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.
Interventions
- DEVICE MRI-guided SBRT
- BEHAVIORAL EORTC QLQ-C30 Questionnaire
- BEHAVIORAL EORTC QLQ-OV28 Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-12-02 |
| Est. Completion | 2018-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02582931
The ClinicalTrials.gov registry entry for NCT02582931 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MRI-guided SBRT is the first listed.
NCT02582931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02582931 about?
NCT02582931 is a clinical study titled "MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer". The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treat...
What is the current status of trial NCT02582931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-12-02. Estimated completion is 2018-12-13.
What interventions are being tested in trial NCT02582931?
The interventions under investigation include: MRI-guided SBRT (DEVICE), EORTC QLQ-C30 Questionnaire (BEHAVIORAL), EORTC QLQ-OV28 Questionnaire (BEHAVIORAL).
Who is sponsoring clinical trial NCT02582931?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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