NCT05301101

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 toxicities among them will be tabulated. The Grade 3-5 toxicity rate among treated patients will be estimated separately for each OAR using the sample proportion and a 90% Wilson score confidence interval. Only patients who initiate re-irradiation therapy will be included in this analysis.

Conditions

• Solid Tumor

Interventions

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

Timeline

• Start date: 2022-06-13
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2022-03-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study