High Dose Re-Irradiation for Solid Tumors

This study is looking at a specific way to give radiation therapy again (re-irradiation) to people with solid tumors. It uses advanced imaging and calculations to plan the treatment and understand how much radiation different organs (like the spinal cord or stomach) receive. The goal is to see how safe this re-irradiation approach is by tracking serious side effects (toxicity) in specific organs for up to 24 months. You might be able to join if you are 18 or older, have a solid tumor, and have had radiation therapy before. The study is currently unclear on its status and plans to enroll 120 participants.

Study design
This is an interventional study planning to enroll 120 participants. It aims to assess toxicity rates for 8 specific organs at risk, with 15 patients per organ.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 24 months to track organ-specific toxicity.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05301101

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

Recruiting
NAAges 18+InterventionalTreatment
Medical College of Wisconsin
~120 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Re-irradiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Organ-specific grade 3 toxicity.
Measured over Up to 24 months
+2 more outcomes measured
Solid Tumor

NCT05301101

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Froedtert Hospital

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Elizabeth Gore, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
Medical College of Wisconsin Cancer Center Clinical Trials Office
Email the study team

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Eligibility criteria

Inclusion

Aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN) or \< 5 x ULN with metastatic liver disease.
Total bilirubin \< 1.5 x ULN
Absolute neutrophil count (ANC) \> 500 cells/mm\^3
Platelets \> 50,000 cells/mm\^3
Creatinine \< 1.5 x ULN or Creatinine clearance \> 45 mL/min if creatinine is \> 1.5 x ULN (calculated Creatinine Clearance (CrCl) based on Cockcroft-Gault equation) 13. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2. 14. Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2. 15. Life expectancy of at least 6 months. 16. Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation. 17. Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English). 18. Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed.
  • Organ-specific grade 3 toxicity.Up to 24 months

    The number of patients with organ-specific grade 3 toxicity in patients undergoing high-dose re-irradiation. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 will be used to define the grade.

  • Organ-specific grade 4 toxicity.Up to 24 months

    The number of patients with organ-specific grade 4 toxicity in patients undergoing high-dose re-irradiation. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 will be used to define the grade.

  • Organ-specific grade 5 toxicity.Up to 24 months

    The number of patients with organ-specific grade 5 toxicity in patients undergoing high-dose re-irradiation. Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 will be used to define the grade.