Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05301101

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

Led by Medical College of Wisconsin · Updated on 2025-06-29

120

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent provided
  • Age 18 years or older receiving high dose radiation overlapping previously irradiated organs at risk
  • Prior radiation dosimetry available
  • Stage I-IV biopsy or cytology proven solid tumor malignancy
  • Recommended histologic confirmation of target lesion recurrence
  • Multidisciplinary team consensus recommending re-irradiation with documented target lesion or postoperative site
  • Documentation of concurrent cancer therapy drugs use and rationale
  • Documented rationale if tissue confirmation of target lesion is not obtained
  • Baseline imaging (CT, PET/CT, or MRI) within six weeks before enrollment
  • Eligible if disease resected in previously irradiated field and at high risk of recurrence
  • Measurable disease not required for postoperative treatment
  • Baseline labs meeting specified limits for liver, kidney, blood counts
  • ECOG performance score 0-2
  • Resolution of acute toxic effects from recent cancer therapy to Grade 1 or 2
  • Life expectancy of at least 6 months
  • Female patients of childbearing potential must have negative pregnancy test within 7 days before treatment
  • Ability to complete self-reported questionnaires
  • Concurrent participation in other clinical trials involving re-irradiation allowed
Not Eligible

You will not qualify if you...

  • Receiving low dose radiation only for symptom management
  • Severe or uncontrolled systemic conditions
  • Life expectancy less than 6 months
  • ECOG performance status of 3 or higher
  • Women of childbearing potential who are pregnant or unwilling to use contraception during radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

M

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

S

Sara Herr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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