Back to resultsMRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
Primary Purpose
Cancer of Ovary, Cancer of the Ovary, Neoplasms, Ovarian
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRI-guided SBRT
EORTC QLQ-C30 Questionnaire
EORTC QLQ-OV28 Questionnaire
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Ovary
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.
- Deemed medically fit for stereotactic body radiation therapy by the treating physician.
- At least 18 years old.
- Karnofsky Performance Status ≥ 70
- Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
- Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).
Exclusion Criteria:
- Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT
- Current central nervous systemic disease.
- Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).
- Actively receiving any investigational agents.
- Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Medical contraindication to undergoing MR imaging.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: MRI-guided SBRT
Arm Description
Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments. Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV. All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
Outcomes
Primary Outcome Measures
Feasibility of providing online, adaptive MRI-guided and gated SBRT as measured by the ability to deliver a full course of MRI-guided SBRT in at least 80% of eligible patients who have completed simulation and planning
Secondary Outcome Measures
Safety as measured by acute toxicities
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Safety as measured by late toxicities
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Response rate
-Response will be measured using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
In-field control rate
Local control rate
Regional control rate
Distant control rate
Progression-free survival (PFS) rate
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Disease-free survival (DFS) rate
-The length of time that a patient survives without any signs or symptoms of their cancer
Overall survival (OS) rate
Patient-reported health-related quality of life (HRQOL)
HRQOL will be measured using the EORTC QLQ-C30 and QLQ-OV28 questionnaires.
European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 consists of 28 questions with answers that range from 1 (Not At All) to 4 (Very Much) and 2 questions that range from 1 (Very Poor) to 7 (Excellent)
EORTC QLQ-OV28 consists of 28 questions ranging with answers from 1 (Not At All) to 4 (Very Much)
CA-125 response levels
Full Information
NCT ID
NCT02582931
First Posted
October 20, 2015
Last Updated
January 15, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02582931
Brief Title
MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
Official Title
Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
May 14, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treatment machine. To best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. The prescription dose will be determined based on hard normal tissue constraints, and capped at 10Gy per fraction. Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Ovary, Cancer of the Ovary, Neoplasms, Ovarian, Ovarian Cancer, Ovary Cancer, Ovary Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: MRI-guided SBRT
Arm Type
Experimental
Arm Description
Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.
Patients will be planned for an initial dose of 35Gy to the planning target volume (PTV), with dose adaptation and reduction allowed based on safety constraints that are generally accepted, up to a maximum allowed total dose of 50Gy in five fractions to the PTV.
All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
Intervention Type
Device
Intervention Name(s)
MRI-guided SBRT
Other Intervention Name(s)
MRI-guided stereotactic body radiation therapy
Intervention Type
Behavioral
Intervention Name(s)
EORTC QLQ-C30 Questionnaire
Intervention Description
30 questions with 28 questions having answers that range from 1 (not at all) to 4 (very much) and the other 2 questions have answers that range from 1 (very poor) to 7 (excellent)
Intervention Type
Behavioral
Intervention Name(s)
EORTC QLQ-OV28 Questionnaire
Intervention Description
28 questions having answers that range from 1 (not at all) to 4 (very much)
Primary Outcome Measure Information:
Title
Feasibility of providing online, adaptive MRI-guided and gated SBRT as measured by the ability to deliver a full course of MRI-guided SBRT in at least 80% of eligible patients who have completed simulation and planning
Time Frame
Completion of all enrolled patients (up to 2 years)
Secondary Outcome Measure Information:
Title
Safety as measured by acute toxicities
Description
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time Frame
Up to 90 days post completion of treatment
Title
Safety as measured by late toxicities
Description
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time Frame
91 days to 6 months post completion of treatment
Title
Response rate
Description
-Response will be measured using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009].
Time Frame
3 months post treatment
Title
In-field control rate
Time Frame
6 months post treatment
Title
Local control rate
Time Frame
3 months post treatment
Title
Regional control rate
Time Frame
3 months post treatment
Title
Distant control rate
Time Frame
3 months post treatment
Title
Progression-free survival (PFS) rate
Description
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time Frame
6 months post treatment
Title
Disease-free survival (DFS) rate
Description
-The length of time that a patient survives without any signs or symptoms of their cancer
Time Frame
6 months post treatment
Title
Overall survival (OS) rate
Time Frame
6 months post treatment
Title
Patient-reported health-related quality of life (HRQOL)
Description
HRQOL will be measured using the EORTC QLQ-C30 and QLQ-OV28 questionnaires.
European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 consists of 28 questions with answers that range from 1 (Not At All) to 4 (Very Much) and 2 questions that range from 1 (Very Poor) to 7 (Excellent)
EORTC QLQ-OV28 consists of 28 questions ranging with answers from 1 (Not At All) to 4 (Very Much)
Time Frame
6 months post treatment
Title
CA-125 response levels
Time Frame
6 months post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.
Deemed medically fit for stereotactic body radiation therapy by the treating physician.
At least 18 years old.
Karnofsky Performance Status ≥ 70
Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).
Exclusion Criteria:
Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT
Current central nervous systemic disease.
Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).
Actively receiving any investigational agents.
Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Medical contraindication to undergoing MR imaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifford Robinson, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
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MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
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