CompletedNCT03325634Updated Oct 23, 2025

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

A Phase 1 interventional study of Laboratory Biomarker Analysis and Quality-of-Life Assessment in Recurrent Endometrial Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-23.

Sponsored by University of Colorado, Denver · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

Study 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.

Read the 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.

Conditions studied

Recurrent Endometrial Serous Adenocarcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
Treatment (SBRT)
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Body Radiation Therapy

Interventions

OtherLaboratory Biomarker Analysis
Correlative studies
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment
OtherQuestionnaire Administration
Ancillary studies
RadiationStereotactic Body Radiation Therapy
Undergo SBRT
Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

What researchers measure

Primary outcomes

Maximum Tolerated Dose
This will be accomplished using the standard 3+3 dose escalation design. Dose Limiting Toxicities (DLTs) will be determined through the NCI CTCAE version 4.03.
Time frame: After the completion of SBRT treatment through 3 months of followup.

Secondary outcomes

One Year Local Control
Local Control will be defined as Stable Disease (SD), Partial Response (PR) or Complete Repsonse (CR) according to RECIST 1.1 criteria. Assessed using Kaplan Meier survival curves.
Time frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.
Progression Free Survival
The amount of time a patient survives without worsening of disease, according to RECIST 1.1 criteria. Assessed using Kaplan Meier survival curves.
Time frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.
Overall Survival
The amount of time a patient survives, with or without progression of disease. Assessed using Kaplan Meier survival curves.
Time frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.
Chemotherapy-Free Interval
The amount of time a patient survives without having to undergo re-initiation of chemotherapy. Assessed using Kaplan Meier survival curves.
Time frame: After the completion of SBRT treatment throughout followup to the re-initiation of chemotherapy, up to one year.
Acute Toxicities
Acute toxicities will be assessed by the NCI CTCAE version 4.03.
Time frame: During SBRT treatment, throughout followup, or death, whichever comes first, up to 6 weeks post treatment.
Late Toxicities
Delayed toxicities will be assessed by the NCI CTCAE version 4.03.
Time frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.
Quality of Life Assessment through Survey
Quality of life will be assessed through the EORTC QLQ-C30 and OV28 questionnaires.
Time frame: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.
Functional Imaging
DCE-CT scans using the Siemens AS open scanner will be assessed according to RECIST 1.1 criteria.
Time frame: Prior to completion of SBRT, immediately after the completion of SBRT, and 6 weeks after the completion of SBRT.
Profile of SBRT-Associated Immune Response
The Human Immune Monitoring Shared Resource will preform cytometry and cytokine arrays, as well as characterizing activation markers.
Time frame: Prior to completion of SBRT, 2 weeks after the completion of SBRT, and 6 weeks after the completion of SBRT.

Study locations

1 site

University of Colorado Hospital
Aurora, Colorado 80045, United States

References and documents

Publications

Robin TP, Hu J, Jones BL, Patton T, Diamond JR, Behbakht K, Lefkowits C, Corr BR, Fisher CM. Phase I trial of stereotactic body radiation therapy (SBRT) for limited site locoregional recurrences of ovarian cancer. Gynecol Oncol. 2025 Sep;200:175-179. doi: 10.1016/j.ygyno.2025.07.023. Epub 2025 Aug 20. PubMed 40839922 ↗

Registry details

Key details

Study ID: NCT03325634
Lead sponsor: University of Colorado, Denver
Responsible party: Sponsor
First posted: Oct 30, 2017
Start date: Oct 27, 2017
Primary completion: Nov 10, 2020
Completion: Oct 20, 2025
Last update: Oct 23, 2025

Study contacts

Christine Fisher, MD

principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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