Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT02582931
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 1
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: MRI-guided stereotactic body radiation therapy
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)
28 questions having answers that range from 1 (not at all) to 4 (very much)
Time frame: Completion of all enrolled patients (up to 2 years)
Time frame: Up to 90 days post completion of treatment
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
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: 3 months post treatment
-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: 6 months post treatment
Time frame: 3 months post treatment
Time frame: 3 months post treatment
Time frame: 3 months post treatment
Time frame: 6 months post treatment
-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
-The length of time that a patient survives without any signs or symptoms of their cancer
Time frame: 6 months post treatment
Time frame: 6 months post treatment
Time frame: 6 months post treatment
Washington University School of Medicine
Other
Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06268665
Adnexal Diseases, Breast Cancer
Sacramento, California, United States
View Trial DetailsNCT03133286
Adnexal Diseases, Anus Diseases
Compton, California, United States
View Trial DetailsNCT05246462
Adnexal Diseases, Cancer of Ovary
Trabzon, Turkey (+90), Turkey (Türkiye)
View Trial DetailsNCT01595204
Adnexal Diseases, Cancer of Ovary
View Trial Details