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

NCT05301101 | Recruiting DMC FDA Device

• 1 other identifier: PRO00042951
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Keywords

high dose radiation; re-irradiation

Outcome Measures

Primary Outcomes (3)

• Organ-specific grade 3 toxicity.

  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.

  Up to 24 months

• Organ-specific grade 4 toxicity.

  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.

  Up to 24 months

• Organ-specific grade 5 toxicity.

  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.

  Up to 24 months

Study Arms (1)

Cancer patients receiving definitive radiation therapy with overlap of a previously treated field

EXPERIMENTAL

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.

Radiation: Re-irradiation

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.

Cancer patients receiving definitive radiation therapy with overlap of a previously treated field

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed informed consent
• Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s).
• Prior radiation dosimetry must be available.
• 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.
• Histologic confirmation of target lesion recurrence is recommended.
• Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated.
• Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale.
• Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable.
• Baseline target lesion imaging with CT, positron emission tomography (PET) /CT, or MRI is required within six weeks of trial enrollment. CT or MRI simulation scans may be used for baseline imaging.
• Patients who have had disease resected in a previously irradiated field and are at high pathological and clinical risk for recurrence as defined by the treating Radiation Oncologist and multidisciplinary team, are eligible for study.
• Measurable disease is not required for patients being treated postoperatively.
• Baseline labs are per standard practice. Values will be dependent on the OARs being treated. (Per standard practice, radiation therapy volumes to OARs are modified to accommodate compromised renal, liver, pulmonary or other OAR function). Recommended labs and values include:
• 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

You may not qualify if:

• Patients receiving low dose radiation for symptom management only.
• Patients with evidence of severe or uncontrolled systemic conditions.
• Life expectancy of less than 6 months.
• ECOG Performance status ≥ 3.
• Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Interventions

Re-Irradiation

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Retreatment

Study Officials

• Elizabeth Gore, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Sara Herr

CONTACT

414-805-4365; sherr@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: June 13, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)