Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02950025 · ClinicalTrials.gov registry record · Phase 2
Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT02950025 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 5 participants.
The verdict
NCT02950025, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
In light of this new technology and preliminary findings of low toxicity of online, adaptive, magnetic resonance (M)-guided stereotactic radiation on a single arm prospective study, the investigators propose to compare this technique to online MR-guided stereotactic body radiation therapy (SBRT) without adaptation. Online plan adaptation increases treatment times for patients and comprises an increased burden on technical and clinical staff. Although preliminary trial results are encouraging, it remains unclear if the dosimetric benefits of online-adaptive planning studies will translate to measurable improvements in clinical outcomes that merit its routine use. In our preliminary study, plan adaptation was most often required when tumors were adjacent to the gastrointestinal tract (the esophagus to the sigmoid colon), as those structures were most commonly the dose-limiting structures and were noted to change in location on a day-to-day basis. For these reasons, abdominal disease sites have historically highlighted the limitations of SBRT. Specifically, the investigators will enroll patients with oligometastatic or unresectable primary disease of the non-liver abdomen to a randomized, prospective trial. Patients will be randomized to one of two treatment arms, in which they will receive either online-adaptive, MRI-guided SBRT or non-adaptive MRI-guided SBRT. Both patient groups will undergo MRI simulation and MRI treatment localization with online MR monitoring and/or gating. All patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, the investigators expect toxicity to be within the current standard of care for the non-adaptive arm, with reduction in toxicity in the arm of patients who undergo adaptation based on daily anatomic changes.
Interventions
- DEVICE Online, adaptive MR-guided SBRT
- DEVICE Online, non-adaptive MR-guided SBRT
- OTHER European Organization for Research and Treatment of Cancer (EORTC) QLQ-30
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2018-03-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02950025
The ClinicalTrials.gov registry entry for NCT02950025 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 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 Online, adaptive MR-guided SBRT is the first listed.
NCT02950025 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02950025 about?
NCT02950025 is a clinical study titled "Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies". In light of this new technology and preliminary findings of low toxicity of online, adaptive, magnetic resonance (M)-guided stereotactic radiation on a single arm prospective study, the investigators propose to compare this technique to online MR-guided stereotactic body radiation therapy (SBRT) wit...
What is the current status of trial NCT02950025?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2017-01-19. Estimated completion is 2018-03-19.
What interventions are being tested in trial NCT02950025?
The interventions under investigation include: Online, adaptive MR-guided SBRT (DEVICE), Online, non-adaptive MR-guided SBRT (DEVICE), European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 (OTHER).
Who is sponsoring clinical trial NCT02950025?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.