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

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05301101
Collaborator
(none)
90
60

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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)
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2027

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Organ-specific grade 3 toxicity. [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. [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. [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Baseline target lesion imaging with CT, positron emission tomography (PET) /CT, or MRI is required within six weeks of trial enrollment.

  2. 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.

  3. Measurable disease is not required for patients being treated postoperatively.

  4. 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)

  1. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.

  2. Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2.

  3. Life expectancy of at least 6 months.

  4. Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation.

  5. Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English).

  6. 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

Locations

No locations specified.

Sponsors and Collaborators

  • Medical College of Wisconsin

Investigators

  • Principal Investigator: Elizabeth Gore, MD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth Gore, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT05301101
Other Study ID Numbers:
  • PRO00042951
First Posted:
Mar 29, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Professor, Medical College of Wisconsin

Study Results

No Results Posted as of Jun 14, 2022