Solid TumorREDIRICTNCT05301101
High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis
A study testing Re-irradiation in people with Solid Tumor, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Re-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Medical College of Wisconsin Clinical Trials Office, 866-680-0505 ext. 8900, cccto@mcw.edu
Sara Herr, 414-805-4365, sherr@mcw.edu
About this study
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)
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.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- Re-irradiation
- Keywords
- high dose radiation, re-irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-irradiationRadiation
Patients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start13 Jun 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Gore, Medical College of Wisconsin
- Investigators
- Elizabeth Gore, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301101
- Sponsor's protocol ID
- PRO00042951
- Acronym
- REDIRICT
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05301101
- Acronym / sponsor ID
- REDIRICT / PRO00042951
- Conditions
- Solid Tumor
- Keywords
- high dose radiation, re-irradiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients receiving definitive radiation therapy with overlap of a previously treated field | Experimental | Radiation: Re-irradiationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-irradiationPatients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams. | Radiation | Cancer patients receiving definitive radiation therapy with overlap of a previously treated field |
Primary outcome
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.
Organ-specific grade 4 toxicity.
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Elizabeth Gore, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-irradiation in people with Solid Tumor, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ-specific grade 3 toxicity. (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.