A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma

University of Colorado, Denver1 site in 1 country15 target enrollmentOctober 27, 2017

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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent Endometrial Serous Adenocarcinoma
Sponsor: University of Colorado, Denver
Enrollment: 15
Locations: 1
Primary Endpoint: Maximum Tolerated Dose
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 27, 2017

End Date

October 20, 2025

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Colorado, Denver

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female patients \> 18 years of age.
•ECOG 0 or
•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.

Outcomes

Primary Outcomes

Maximum Tolerated Dose

Time Frame: 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 Outcomes

One Year Local Control(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.)
Functional Imaging(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(Prior to completion of SBRT, 2 weeks after the completion of SBRT, and 6 weeks after the completion of SBRT.)
Chemotherapy-Free Interval(After the completion of SBRT treatment throughout followup to the re-initiation of chemotherapy, up to one year.)
Quality of Life Assessment through Survey(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.)
Acute Toxicities(During SBRT treatment, throughout followup, or death, whichever comes first, up to 6 weeks post treatment.)
Late Toxicities(After the completion of SBRT treatment, throughout followup, or death, whichever comes first, up to one year.)