High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis (REDIRICT)
Medical College of Wisconsin
Summary
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.
Description
STUDY DESIGN: For each serial OAR, we expect that 10% or less of reirradiated patients will have a Grade 3-5 toxicity. Under this assumption, 15 patients treated at a defined OAR will provide a 90% confidence interval (CI) for the Grade 3-5 OAR toxicity rate with a CI width no larger than 29%. A total of 120 treated patients (15 per OAR) are needed to provide this level of precision for toxicity rates within all 8 OARs (spinal cord, brachial plexus, named vessels, esophagus, duodenum, rectum, proximal bronchus/trachea, liver). For each OAR, the numbers of patients reirradiated and Grade 3-5 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed informed consent 2. Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s). 3. Prior radiation dosimetry must be available. 4. Participants must have stage I-IV biopsy proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site). Documentation of pathology reports are required. Local review of pathology or cytology is at the discretion of the multidisciplinary team. 5. Histol…
Interventions
- RadiationRe-irradiation
Patients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.
Location
- Froedtert HospitalMilwaukee, Wisconsin