Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer

Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:October 27, 2017
End Date:July 21, 2021

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A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma

This phase I trial studies the side effects and best dose of stereotactic body radiation
therapy in treating patients with ovarian or uterine cancer that has come back. Stereotactic
body radiation therapy is a specialized radiation therapy that sends x-rays directly to the
tumor using smaller doses over several days and may cause less damage to normal tissue.

This is a phase I study with a primary objective to determine maximum tolerated dose (MTD) of
3 fraction stereotactic body radiation therapy (SBRT) for abdominopelvic recurrences of
ovarian cancer (OC) and uterine papillary serous carcinoma (UPSC). This is a dose escalation
study that employs a 3+3 design to determine the MTD. Patients are then monitored closely to
determine side effects and adverse events, as well as success rates and tumor response to the
radiation therapy.

Inclusion Criteria:

- Female patients > 18 years of age.

- ECOG 0 or 1.

- Diagnosis of primary ovarian cancer of any histology (patients with diagnoses of
fallopian tube and primary peritoneal cancer are also eligible), or primary uterine
cancer of papillary serous histology.

- Pathologic confirmation of eligible histology.

- Three or fewer total sites of active disease (at least one site of active disease to
be treated on study must be confined to the abdomen or pelvis excluding liver and must
be < 5 cm in greatest dimension as determined by pre-screening cross-sectional

- Additional site(s) of active disease (such as parenchymal liver and lung metastases,
or supraclavicular nodal metastases), should be considered for treatment (off study)
with radiation, surgery, or another form of local therapy, at the discretion of the
study PI.

- Systemic therapy is allowed but SBRT cannot begin until > or = 7 days after the last
cycle of systemic therapy, and systemic therapy cannot be initiated or re-initiated
until > or = 7 days after SBRT. There will be no limit on prior lines of systemic

- Patients with contraindications to intravenous (IV) contrast administration are still
eligible for this study if the tumor can be delineated clearly without IV contrast (at
the discretion of the treating radiation oncologist) but will not participate in the
functional imaging studies.

Exclusion Criteria:

- Pregnant women. If patients are not status post bilateral salpingo-oopherectomy then
pregnancy testing is required.

- Patients with active collagen vascular disease (CVD), specifically systemic lupus
erythematosus or scleroderma. Patients with a history of CVD without evidence of
active disease are eligible for enrollment at the discretion of the study PI.

- Patients with inflammatory bowel disease and/or GI ulcers and/or GI fistulas are
eligible but only at the discretion of the study PI after personalized review of their
medical history and proximity of SBRT targets to gastrointestinal mucosa.

- Patients with a separate non-cutaneous cancer diagnosis for which the patient has not
been without evidence of disease for at least 5 years.
We found this trial at
12605 East 16th Avenue
Aurora, Colorado 80045
Principal Investigator: Christine M. Fisher
Phone: 720-848-0154
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
Aurora, CO
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