MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer



Status:Completed
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:December 2, 2015
End Date:December 13, 2018

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Pilot Study of 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 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.


Inclusion Criteria:

- Histologically or cytologically confirmed primary disease histology of solid ovarian,
fallopian tube, or primary peritoneal tumor categorization.

- Deemed medically fit for stereotactic body radiation therapy by the treating
physician.

- At least 18 years old.

- Karnofsky Performance Status ≥ 70

- Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at
least one week prior to planned start of SBRT (two weeks preferred) and must have no
plans to initiate systemic therapy for at least one week following end of SBRT (two
weeks preferred).

- Able to understand and be willing to sign an IRB approved written informed consent
document (or legally authorized representative, if applicable).

Exclusion Criteria:

- Past history of radiotherapy within the projected treatment field of any of the
disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT

- Current central nervous systemic disease.

- Widespread progressive disease, i.e., more than three sites of progressive disease
(note that more than three sites of disease are permitted provided there are no more
than three sites of progressive disease).

- Actively receiving any investigational agents.

- Presence of uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

- Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative
pregnancy test within 14 days of study entry.

- Medical contraindication to undergoing MR imaging.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Clifford Robinson, M.D.
Phone: 314-362-8567
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
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Saint Louis, MO
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