We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05301101
Recruitment Status : Recruiting
First Posted : March 29, 2022
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
Elizabeth Gore, Medical College of Wisconsin

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Solid Tumor Radiation: Re-irradiation

Detailed Description:

STUDY DESIGN: For each serial OAR, the investigators expect that 10% or less of re-irradiated subjects will have a grade 3-5 toxicity. Under this assumption, 15 subjects 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 90 treated subjects (15 per OAR) are needed to provide this level of precision for toxicity rates within all six OARs (spinal cord, brachial plexus, named vessels, esophagus, duodenum, rectum).

For each OAR, the numbers of subjects re-irradiated 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 subjects who initiate re-irradiation therapy will be included in this analysis.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2027
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 Radiation: Re-irradiation
Patients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients receiving definitive radiation therapy with overlap of a previously treated field.
Criteria

Inclusion 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. Discussion with the disease site specific multidisciplinary team is required. Documentation must include;

    • Consensus for recommendation of reirradiation and location of target lesion or postoperative site to be treated.
    • Whether or not concurrent cancer therapy drugs are recommended and rationale.
    • Rationale for not obtaining tissue confirmation of the target lesion, if applicable.
  7. Baseline target lesion imaging with CT, positron emission tomography (PET) /CT, or MRI is required within six weeks of trial enrollment.
  8. 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. The surgeon must clear the patient for radiation therapy prior to initiating treatment.
  9. Measurable disease is not required for patients being treated postoperatively.

  10. Adequate organ and hematologic/bone marrow function within 14 days of starting therapy is required. The 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 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/mm3
    • 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)
  11. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.
  12. Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2.
  13. Life expectancy of at least 6 months.
  14. Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation.
  15. Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English).
  16. Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed.

Exclusion Criteria:

  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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05301101


Contacts
Layout table for location contacts
Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 866-680-0505 ext 8900 cccto@mcw.edu
Contact: Sara Herr 414-805-4365 sherr@mcw.edu

Locations
Layout table for location information
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Medical College of Wisconsin Clinical Trials Office    866-680-0505 ext 8900    cccto@mcw.edu   
Contact: Sara Herr    414-805-4365    sherr@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Layout table for investigator information
Principal Investigator: Elizabeth Gore, MD Medical College of Wisconsin
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Elizabeth Gore, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT05301101    
Other Study ID Numbers: PRO00042951
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elizabeth Gore, Medical College of Wisconsin:
high dose radiation
re-irradiation