Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176, United States
NCT Number: NCT06397573
This research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. The purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "reRT." The researchers want to find out what effects (good and bad) reRT has in people with cancer in the abdomen and pelvis.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Miami, Florida, 33176, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ablative reirradiation of 50 Gy in 5 fractions (5 sessions) that will occur once per day, either for 5 days in a row, or every other day.
Time frame: 1 year
Number of participants who experience Grade 3 or higher acute toxicity [graded per Common Terminology Criteria for Adverse Events (CTCAE)] possibly, probably, or definitely related to reRT.
Time frame: 1 year
Number of participants who experience Grade 5 toxicity (graded per CTCAE) possibly, probably, or definitely related to reRT.
Time frame: 1 year
FFLP is defined as the duration of time from baseline to progressive disease (PD) in the re-irradiated lesion or death of any cause, whichever occurs first. Response to treatment will be assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: 1 year
OS is defined as the defined as the duration of time from baseline to death of any cause, or date of last follow-up, whichever occurs first.
Time frame: 1 year
Number of participants who experience Grade 3 or higher acute toxicity [graded per Common Terminology Criteria for Adverse Events (CTCAE)] possibly, probably, or definitely related to reRT that occurs at least 90 days after reRT therapy has ended.
Time frame: 1 year
QOL will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire measuring physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much), with a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher scores indicate better QOL.
Baptist Health South Florida
Other
Phase 1 Trial of Ablative Stereotactic MR-Guided Adaptive Reirradiation for Abdominal and Pelvic Tumors
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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.
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