- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05301101
High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis (REDIRICT)
High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis (REDIRICT)
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Herr
- Phone Number: 414-805-4365
- Email: sherr@mcw.edu
Study Contact Backup
- Name: Medical College of Wisconsin Cancer Center Clinical Trials Office
- Phone Number: 8900 866-680-0505
- Email: cccto@mcw.edu
Study Locations
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-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Froedtert Hospital
-
Contact:
- Medical College of Wisconsin Clinical Trials Office
- Phone Number: 8900 866-680-0505
- Email: cccto@mcw.edu
-
Contact:
- Sara Herr
- Phone Number: 414-805-4365
- Email: sherr@mcw.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- 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
- 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)
- Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
- Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2.
- Life expectancy of at least 6 months.
- Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation.
- Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English).
- Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cancer patients receiving definitive radiation therapy with overlap of a previously treated field
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.
|
Patients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Organ-specific grade 3 toxicity.
Time Frame: 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.
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Up to 24 months
|
Organ-specific grade 4 toxicity.
Time Frame: Up to 24 months
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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.
Time Frame: 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.
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Up to 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Gore, MD, Medical College of Wisconsin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRO00042951
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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