Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536805
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-08-17
Brief Title:
Relapse in Previously Irradiated Prostate Bed Stereotactic Ablative Reirradiation Potentiated by Metformin
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
Official Title:
Relapse in Previously Irradiated Prostate Bed a Phase III Study of Stereotactic Ablative Reirradiation Potentiated by Metformin
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR
Brief Summary:
This phase III escalation dose study is assessing the efficacy of the recommended dose of stereotactic re-irradiation SBRT of relapses within the prostatectomy bed potentiated by metformin
Detailed Description:
The purpose of this escalation study is first to select the recommended dose of re-irradiation SBRT in combination with Metformin based on treatment toxicity monitoring and then to estimate the efficacy of re-irradiation SBRT in combination with Metformin
Five or six fractions at a level of 5 or 6 Gray Gy per session either 5 x 6 Gy 6 x 6 Gy or 5 x 5 Gy will be delivered over a maximum of 12 days from day 1 to day 10 or 12 to provide a total dose of 25 to 36 Gy
Patient receive oral Metformin treatment from Day -15 and Day 75
Patient will be followed for 5 years patients visits will be planned at week 2 4 8 12 and month M6 M9 M12 M18 M24 M36 4 years and 5 years
Five or six fractions at a level of 5 or 6 Gray Gy per session either 5 x 6 Gy 6 x 6 Gy or 5 x 5 Gy will be delivered over a maximum of 12 days from day 1 to day 10 or 12 to provide a total dose of 25 to 36 Gy
Patient receive oral Metformin treatment from Day -15 and Day 75
Patient will be followed for 5 years patients visits will be planned at week 2 4 8 12 and month M6 M9 M12 M18 M24 M36 4 years and 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None