Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549439
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-15
Brief Title:
eFLASH for Skin Lesions of Malignant Melanomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Study on Feasibility and Toxicity of LINAC-based Flash Radiotherapy for Palliative Treatment of Skin Lesions of Malignant Melanomas
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:
Flash-Skin I
Brief Summary:
This prospective single center phase I trials aims to assess feasibility and safety of electron FLASH RT for treatment of melanoma skin metastases Feasibility will be defined as FLASH delivery with an accuracy of -10 for each fraction safety will be confirmed if a maximum of 2 out of 6 patients develop dose limited toxicity
Detailed Description:
Trial aim
This prospective single center phase I trial aims to assess feasibility and safety of electron Flash RT for treatment of melanoma skin metastases Feasibility will be defined as Flash delivery with an accuracy of 10 for at least 10 out of 12 Flash-RT fractions and the accuracy of the total reference dose delivered 3x 9 Gy is 5 safety will be confirmed if a maximum of 2 out of 6 patients develop dose-limiting toxicity
Intervention Flash
A nominal electron energy of 9 MeV will be used for both Flash-RT and Conv-RT which guarantees 90 dose coverage up to a depth of 28 cm Shallower lesions will be treated with the same electron energy and with a bolus In order to treat these patients field sizes between 2x2cm2 and 10x10cm2 will be used which can be delivered with sufficient flatness 5 and symmetry 2 by the FlashTrueBeam v275
Trial outline
In the primary cohort six patients with 1 melanoma skin lesions possible other lesions do not have to be treated will be treated with a radiotherapy schedule of 3x 9 Gy 2x fractions week αβ3 EQD2 648 Gy αβ10 EQD2 4275 Gy A minimum of one lesion will be treated with Flash-RT 2x 9 Gy and Conv-RT 1x 9 Gy as experimental treatment and an optional minimum of one lesion will be treated with Conv-RT 3x 9 Gy as internal control As a consequence also patients with a single lesion can be included into the trial For the experimental treatment the first two fractions will be applied with Flash-RT Following dosimetry of these two fractions the third fraction will be applied by Conv-RT and will be adjusted to compensate for possible lower or higher doses applied with Flash-RT before This approach ensures that every lesion is treated with precisely a total reference dose of 27 Gy 5 ultimately
In an optional expansion cohort up to 4 additional patients total of n10 will be recruited The expansion cohort serves to further validate the primary results The initiation of the expansion cohort requires to following three factors 1 A maximum of 2 out of 6 patients develop DLT an no unexpected high-grade toxicity appear in the primary cohort 2 Feasibility in the first six patients was shown defined as Flash delivery with an accuracy of 10 for at least 10 out of 12 Flash-RT fractions and the accuracy of the total reference dose delivered 3x 9 Gy of 5 3 No excessive duration in the recruitment of the primary cohort Patients will be included and treated into the expansion cohort as in the primary cohort
This prospective single center phase I trial aims to assess feasibility and safety of electron Flash RT for treatment of melanoma skin metastases Feasibility will be defined as Flash delivery with an accuracy of 10 for at least 10 out of 12 Flash-RT fractions and the accuracy of the total reference dose delivered 3x 9 Gy is 5 safety will be confirmed if a maximum of 2 out of 6 patients develop dose-limiting toxicity
Intervention Flash
A nominal electron energy of 9 MeV will be used for both Flash-RT and Conv-RT which guarantees 90 dose coverage up to a depth of 28 cm Shallower lesions will be treated with the same electron energy and with a bolus In order to treat these patients field sizes between 2x2cm2 and 10x10cm2 will be used which can be delivered with sufficient flatness 5 and symmetry 2 by the FlashTrueBeam v275
Trial outline
In the primary cohort six patients with 1 melanoma skin lesions possible other lesions do not have to be treated will be treated with a radiotherapy schedule of 3x 9 Gy 2x fractions week αβ3 EQD2 648 Gy αβ10 EQD2 4275 Gy A minimum of one lesion will be treated with Flash-RT 2x 9 Gy and Conv-RT 1x 9 Gy as experimental treatment and an optional minimum of one lesion will be treated with Conv-RT 3x 9 Gy as internal control As a consequence also patients with a single lesion can be included into the trial For the experimental treatment the first two fractions will be applied with Flash-RT Following dosimetry of these two fractions the third fraction will be applied by Conv-RT and will be adjusted to compensate for possible lower or higher doses applied with Flash-RT before This approach ensures that every lesion is treated with precisely a total reference dose of 27 Gy 5 ultimately
In an optional expansion cohort up to 4 additional patients total of n10 will be recruited The expansion cohort serves to further validate the primary results The initiation of the expansion cohort requires to following three factors 1 A maximum of 2 out of 6 patients develop DLT an no unexpected high-grade toxicity appear in the primary cohort 2 Feasibility in the first six patients was shown defined as Flash delivery with an accuracy of 10 for at least 10 out of 12 Flash-RT fractions and the accuracy of the total reference dose delivered 3x 9 Gy of 5 3 No excessive duration in the recruitment of the primary cohort Patients will be included and treated into the expansion cohort as in the primary cohort
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