High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05301101
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Re-irradiation — RADIATION
    Patients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.

Study Details

This trial applies a uniform approach to re-irradiation for planning and diagnostic image fusion, dose summation, dose calculations, and follow up for tumor control and detailed toxicity analysis of serial Organs At Risk (OARs). Serial organs include named arteries and nerves, spinal cord, and gastrointestinal tract.

Key Dates

Start date
Jun 13, 2022
Status verified
Jun 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cancer patients receiving definitive radiation therapy with overlap of a previously treated field
    This is a re-irradiation study in solid tumor patients receiving definitive high dose radiation therapy to treatment volumes that include overlap with previously irradiated organs at risk.

Primary Outcome Measure

Organ-specific grade 3 toxicity. [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert HospitalMilwaukeeWisconsin53226
Medical College of Wisconsin Clinical Trials Office
[email protected]
866-680-0505
Sara Herr
[email protected]
414-805-4365

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By research site
Froedtert Hospital· Milwaukee, WI

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