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AzTrials

Recurrent Endometrial Serous AdenocarcinomaPhase 1NCT03325634

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

A Phase 1 study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Questionnaire Administration in people with Recurrent Endometrial Serous Adenocarcinoma and Recurrent Fallopian Tube Carcinoma, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Laboratory Biomarker Analysis, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
27 Oct 2017to 20 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: 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.

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.

Being tested
Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo SBRT

Study groups in NCT03325634
Study groupRoleWhat they receive
Treatment (SBRT)ExperimentalPatients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After the completion of SBRT treatment through 3 months of followup.

Secondary outcomes (9)

  1. 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.

    Measured: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.

  2. 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.

    Measured: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.

  3. Overall Survival

    The amount of time a patient survives, with or without progression of disease. Assessed using Kaplan Meier survival curves.

    Measured: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.

  4. Chemotherapy-Free Interval

    The amount of time a patient survives without having to undergo re-initiation of chemotherapy. Assessed using Kaplan Meier survival curves.

    Measured: After the completion of SBRT treatment throughout followup to the re-initiation of chemotherapy, up to one year.

  5. Acute Toxicities

    Acute toxicities will be assessed by the NCI CTCAE version 4.03.

    Measured: During SBRT treatment, throughout followup, or death, whichever comes first, up to 6 weeks post treatment.

  6. Late Toxicities

    Delayed toxicities will be assessed by the NCI CTCAE version 4.03.

    Measured: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.

  7. Quality of Life Assessment through Survey

    Quality of life will be assessed through the EORTC QLQ-C30 and OV28 questionnaires.

    Measured: After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.

  8. Functional Imaging

    DCE-CT scans using the Siemens AS open scanner will be assessed according to RECIST 1.1 criteria.

    Measured: Prior to completion of SBRT, immediately after the completion of SBRT, and 6 weeks after the completion of SBRT.

  9. Profile of SBRT-Associated Immune Response

    The Human Immune Monitoring Shared Resource will preform cytometry and cytokine arrays, as well as characterizing activation markers.

    Measured: Prior to completion of SBRT, 2 weeks after the completion of SBRT, and 6 weeks after the completion of SBRT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2017
  2. Study start27 Oct 2017
  3. Primary completion10 Nov 2020
  4. Study completion20 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03325634
Sponsor's protocol ID
17-1333.cc
Other IDs
NCI-2017-01888
Status last verified
Oct 2025
First submitted
20 Oct 2017
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Questionnaire Administration in people with Recurrent Endometrial Serous Adenocarcinoma and Recurrent Fallopian Tube Carcinoma, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: After the completion of SBRT treatment through 3 months of followup.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03325634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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