Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
Official Title
A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum Tolerated Dose
Secondary Outcome
One Year Local Control
Condition
Recurrent Endometrial Serous Adenocarcinoma
Intervention
Laboratory Biomarker Analysis
Study Arms / Comparison Groups
Treatment (SBRT)
Description: Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
18
Start Date
October 27, 2017
Completion Date
July 21, 2021
Primary Completion Date
December 21, 2020
Eligibility Criteria
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
imaging).
- 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
therapy.
- 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christine Fisher, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03325634
Organization ID
17-1333.cc
Secondary IDs
NCI-2017-01888
Responsible Party
Sponsor
Study Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Christine Fisher, MD, Principal Investigator, University of Colorado, Denver
Verification Date
August 2020