RECRUITING

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

Conditions

Solid Tumor high dose radiation re-irradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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 (REDIRICT)

Quick Facts

Study Start:2022-06-13

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05301101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. Histologic confirmation of target lesion recurrence is recommended. 6. Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated. 7. Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale. 8. Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable. 9. 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. 10. 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. 11. Measurable disease is not required for patients being treated postoperatively. 12. 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 * 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.	1. Patients receiving low dose radiation for symptom management only. 2. Patients with evidence of severe or uncontrolled systemic conditions. 3. Life expectancy of less than 6 months. 4. ECOG Performance status ≥ 3. 5. 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

Inclusion Criteria

Exclusion 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. Histologic confirmation of target lesion recurrence is recommended.
6. Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated.
7. Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale.
8. Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable.
9. 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.
10. 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.
11. Measurable disease is not required for patients being treated postoperatively.
12. 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
* 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.

1. Patients receiving low dose radiation for symptom management only.
2. Patients with evidence of severe or uncontrolled systemic conditions.
3. Life expectancy of less than 6 months.
4. ECOG Performance status ≥ 3.
5. 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

Contacts and Locations

Study Contact

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

Principal Investigator

Elizabeth Gore, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Elizabeth Gore, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-13

Study Completion Date2027-07

Study Record Updates

Study Start Date2022-06-13

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

high dose radiation
re-irradiation

Additional Relevant MeSH Terms

Solid Tumor