Back to resultsStereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
Primary Purpose
Recurrent Endometrial Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Questionnaire Administration
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Endometrial Serous Adenocarcinoma
Eligibility Criteria
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.
Sites / Locations
- University of Colorado Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (SBRT)
Arm Description
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Overall Survival
The amount of time a patient survives, with or without progression of disease. Assessed using Kaplan Meier survival curves.
Chemotherapy-Free Interval
The amount of time a patient survives without having to undergo re-initiation of chemotherapy. Assessed using Kaplan Meier survival curves.
Acute Toxicities
Acute toxicities will be assessed by the NCI CTCAE version 4.03.
Late Toxicities
Delayed toxicities will be assessed by the NCI CTCAE version 4.03.
Quality of Life Assessment through Survey
Quality of life will be assessed through the EORTC QLQ-C30 and OV28 questionnaires.
Functional Imaging
DCE-CT scans using the Siemens AS open scanner will be assessed according to RECIST 1.1 criteria.
Profile of SBRT-Associated Immune Response
The Human Immune Monitoring Shared Resource will preform cytometry and cytokine arrays, as well as characterizing activation markers.
Full Information
NCT ID
NCT03325634
First Posted
October 20, 2017
Last Updated
April 12, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03325634
Brief Title
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
Official Title
A Phase I Study of Stereotactic Body Radiation Therapy for Patients With Limited Locoregional Recurrences of Ovarian and Uterine Serous Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
November 21, 2021 (Actual)
Study Completion Date
November 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Endometrial Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (SBRT)
Arm Type
Experimental
Arm Description
Patients undergo Stereotactic Body Radiation Therapy (SBRT) every other day for 3 fractions.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
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 Outcome Measure Information:
Title
One Year Local Control
Description
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.
Title
Progression Free Survival
Description
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.
Title
Overall Survival
Description
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.
Title
Chemotherapy-Free Interval
Description
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.
Title
Acute Toxicities
Description
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.
Title
Late Toxicities
Description
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.
Title
Quality of Life Assessment through Survey
Description
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.
Title
Functional Imaging
Description
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.
Title
Profile of SBRT-Associated Immune Response
Description
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.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Fisher, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Primary Ovarian or Uterine Cancer
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