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Procedure
Reirradiation for Abdominal and Pelvic Cancer
N/A
Recruiting
Led By Michael Chuong, M.D.
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study.
A primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. There is no maximum lesion size.
Must not have
Uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
Less than 70% of the gross tumor volume (GTV) receives at least 95% of the prescribed dose on the original plan using the simulation day anatomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial will study the effects of giving another round of radiation therapy to people who have cancer in their abdomen or pelvis. Researchers want to see if this treatment, called reirradiation or "
Who is the study for?
This trial is for individuals who have previously undergone radiation therapy for cancer located in the abdomen or pelvis. It aims to explore the safety of administering a second round of radiation, known as reirradiation, to these patients.
What is being tested?
The study is testing the effects and safety of reirradiation (reRT) on tumors within the abdominal and pelvic regions that have already been treated with radiation before. The goal is to understand both positive outcomes and potential harms.
What are the potential side effects?
Possible side effects from reirradiation may include skin changes, fatigue, nausea, diarrhea, and other symptoms related to additional exposure to radiation in tissues that were previously treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My previous and current radiation treatments overlap by at least 50%.
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I have a cancerous lesion in my abdomen or pelvis that needs more radiation.
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It has been over 6 months since I finished my last radiation therapy.
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I have had one round of radiation therapy with a specific dose.
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I am able to get out of my bed or chair and move around.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled brain tumors, spinal issues, or widespread cancer in my brain or spine.
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Less than 70% of my tumor received the full planned dose of radiation.
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I have had more than one radiation treatment to my abdomen or pelvis.
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I have not taken VEGF inhibitors 8 weeks before or after reirradiation.
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I cannot get the digital files of my previous radiation treatment plan.
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I have a history of inflammatory bowel disease.
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I need another round of radiation for multiple areas in my abdomen or pelvis.
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My treatment area is not in my abdomen or pelvis.
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I don't have lasting side effects from cancer treatment.
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I received chemotherapy within a week before or after having more radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade 3 or higher acute toxicity
Grade 5 toxicity
Secondary outcome measures
Freedom from local progression (FFLP)
Grade 3 or higher late toxicity
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ablative ReirradiationExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
50 Previous Clinical Trials
7,869 Total Patients Enrolled
Baptist Health FoundationUNKNOWN
Michael Chuong, M.D.Principal InvestigatorMiami Cancer Institute at Baptist Health, Inc.
1 Previous Clinical Trials
48 Total Patients Enrolled
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