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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Re-irradiation
RadiationPatients will undergo re-irradiation following treatment planning based on current standard practice as determined by treating physicians and multidisciplinary teams.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Sponsors and contacts
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