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Reirradiation Dose Escalation in Thoracic Cancers

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Contents

clinicaltrials.gov/study/NCT06558175
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT065581750
Health Conditions in Trial
Esophageal cancer
Esophageal cancer
0
‌
Lung Cancer
0
Trial Recruitment Size
480
Trial Sponsor
‌
Lawson Health Research Institute
0
Clinical Trial Start Date
October 30, 2024
0
Primary Completion Date
October 30, 2026
0
Study Completion Date
January 29, 2027
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Radiation0
Interventional Trial Phase
Phase 10
Official Name
A Safety and Efficacy Trial of Reirradiation Dose Escalation in Thoracic Cancers: Re-evaluating Previous Dose and Allowing Increasing Recovery (REPAIR)0
Last Updated
August 16, 2024
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
stereotactic body radiation therapy (SBRT)0
Study summary

This is a study involving patients with recurrence, metastasis, or new primary malignancies in the thorax requiring radiation and who have previously received radiotherapy to the thorax, where re-irradiation is expected to exceed the dose constraints used for de novo treatments. Currently, when this group of patients needs another set of radiotherapy, there is a dose limitation based on a percentage of the previous treatment's dose. However, this dose often limits the effectiveness of repeated treatment, with little scientific support for such. Therefore, this study aims to determine the maximally tolerated dose of reirradiation in the thorax, with dose escalation implemented by sequentially increasing the normal tissue recovery factors (i.e. repair factors) to the previously delivered dose. Using a recovery factor equation associated with a 35% or lower rate of grade 3-5 treatment-related toxicity occurring within 1 year of treatment, accrual will start at level 1 (recovery factor = 10% at 6 months + 0.75% per month thereafter). Patients will be assigned to recovery factors using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3-5 toxicity of 35% or less.

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