NCT02582931|CompletedPhase 1DMCFDA Device
MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
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Sponsor study identifier
interventional
10
1 country
1
Study Start
December 2, 2015
Actual (reported)Primary Completion
May 14, 2018
Actual (reported)Study Completion
December 13, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 13, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2015
Actual (reported)October 21, 2015
Actual (reported)December 2, 2015
Actual (reported)May 14, 2018
Actual (reported)December 13, 2018
Actual (reported)Feasibility of providing online, adaptive MRI-guided and gated SBRT as measured by the ability to deliver a full course of MRI-guided SBRT in at least 80% of eligible patients who have completed simulation and planning
Completion of all enrolled patients (up to 2 years)
Safety as measured by acute toxicities
Up to 90 days post completion of treatment
Safety as measured by late toxicities
91 days to 6 months post completion of treatment
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments. * Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV. * All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
30 questions with 28 questions having answers that range from 1 (not at all) to 4 (very much) and the other 2 questions have answers that range from 1 (very poor) to 7 (excellent)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Clifford Robinson, M.D.
Washington University School of Medicine
10 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2015
First Posted
October 21, 2015
Study Start
December 2, 2015
Actual (reported)Primary Completion
Blood Collection From People With Ovarian Cancer
Unesbulin in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy
Response rate
3 months post treatment
In-field control rate
6 months post treatment
Local control rate
3 months post treatment
28 questions having answers that range from 1 (not at all) to 4 (very much)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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May 14, 2018
Actual (reported)Study Completion
December 13, 2018
Actual (reported)Last Updated
January 17, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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