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

NCT03325634 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 17-1333.ccNCI-2017-01888
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• One Year Local Control

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

• Progression Free Survival

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

• Overall Survival

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

• Chemotherapy-Free Interval

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

• Acute Toxicities

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

Study Arms (1)

Treatment (SBRT)

EXPERIMENTAL

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

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 40839922 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christine Fisher, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: October 27, 2017
• Primary Completion: November 10, 2020
• Study Completion: October 20, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (1)