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

ConditionSolid Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Re-irradiation

    Radiation

    Patients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Cancer patients receiving definitive radiation therapy with overlap of a previously treated fieldExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 24 months
2

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.

Time frame
Up to 24 months
3

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.

Time frame
Up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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