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

Phase 1

Completed

• Conditions: Recurrent Endometrial Serous Adenocarcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma
• Interventions: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT03325634
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study First Submitted: 2017-10-20
• Study Start: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-30
• Primary Completion: 2020-11-10
• Study Completion: 2021-11-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SBRT)	Questionnaire Administration	Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Treatment (SBRT)	Quality-of-Life Assessment	Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Treatment (SBRT)	Laboratory Biomarker Analysis	Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Treatment (SBRT)	Stereotactic Body Radiation Therapy	Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	After the completion of SBRT treatment through 3 months of followup.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States