Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558175
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Reirradiation Dose Escalation in Thoracic Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Safety and Efficacy Trial of Reirradiation Dose Escalation in Thoracic Cancers Re-evaluating Previous Dose and Allowing Increasing Recovery REPAIR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR
Brief 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 treatments 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 ie 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 075 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
Currently when this group of patients needs another set of radiotherapy there is a dose limitation based on a percentage of the previous treatments 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 ie 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 075 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
Detailed Description:
The REPAIR trial aims to identify the magnitude of radiation recovery in the thorax and enable safe reirradiation dose escalation The trial will provide critical information to support shared-decision making and ensure the risk-benefit trade-offs of reirradiation align with each patients wishes In addition the data from this study will be informative in guiding subsequent studies on the use of reirradiation for other sites such as the brain abdomen and pelvis and to inform future re-irradiation trials The objective of this phase I study is to determine the safety of dose escalation via recovery factors applied against previously delivered doses for patients receiving thoracic reirradiation
This study will use a time-to-event continual reassessment method TITE-CRM The study design is based on previous thoracic dose escalation trials
The primary endpoint of this study is the maximally tolerated dose MTD of thoracic reirradiation implemented by sequentially increasing the normal tissue recovery factors applied to the previously delivered dose The MTD is the recovery factor equation associated with a 35 rate of grade 3-5 pre-specified treatment-related toxicity occurring within 1 year of treatment
This study will use a time-to-event continual reassessment method TITE-CRM The study design is based on previous thoracic dose escalation trials
The primary endpoint of this study is the maximally tolerated dose MTD of thoracic reirradiation implemented by sequentially increasing the normal tissue recovery factors applied to the previously delivered dose The MTD is the recovery factor equation associated with a 35 rate of grade 3-5 pre-specified treatment-related toxicity occurring within 1 year of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None