NCT03325634CompletedPhase 1
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma
Source: ClinicalTrials.gov · Last updated 23 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 20 Oct 2017
- Start date
- 27 Oct 2017
- Primary completion date
- 10 Nov 2020
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Ovarian cancer
- NCT number
- NCT03325634
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 15
- From 27 Oct 2017 to the primary completion date, 10 Nov 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant women. If patients are not status post bilateral salpingo-oopherectomy then pregnancy testing is required.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.