Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523894
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Ablative SBRT in Elderly BC Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EASE brEAst Stereo Elderly A Phase IaIb Study of Stereotactic Ablative Irradiation as an Alternative to Surgery in Elderly and Comorbid Breast Cancer Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
EASE
Brief Summary:
Stereotactic body radiotherapy SBRT is a modern radiotherapy technique through which extremely high doses of irradiation are delivered in a very precise manner within a few fractions SBRT is increasingly used into clinical practice because it can provide excellent local control comparable to surgery in many tumor locations such as lung liver or bone Efforts to develop it for BC treatment are promising as it is safe convenient and effective To date SBRT for BC has been developed as an alternative method of partial-breast irradiation PBI in the pre- or post-operative setting Therefore the doses tested are comparable to the conventional doses used with surgery although its potential as sole local treatment for BC remains unknown Higher SBRT doses are expected to permit obtaining an ablative effect on tumor and be suitable as an alternative to surgery but this hypothesis has yet to be tested
The aim of the present study is to prove the feasibility of SBRT as an ablative treatment in early breast cancer BC The primary objective is to find the maximum tolerated dose of SBRT that can be safely administered in inoperable patients with BC the majority of whom are elderly or oldest old
The overall objective is to determine whether high precision dose- and fractionation- adapted SBRT is feasible and safe in inoperable patients with BC The dose and fractionation-adapted SBRT regimen permits to test feasibility in different tumor sizes
The primary objective of this study is to establish the maximum tolerated dose MTD that can be delivered with a single or few up to 5 fractions of SBRT in inoperable patients with BC
The aim of the present study is to prove the feasibility of SBRT as an ablative treatment in early breast cancer BC The primary objective is to find the maximum tolerated dose of SBRT that can be safely administered in inoperable patients with BC the majority of whom are elderly or oldest old
The overall objective is to determine whether high precision dose- and fractionation- adapted SBRT is feasible and safe in inoperable patients with BC The dose and fractionation-adapted SBRT regimen permits to test feasibility in different tumor sizes
The primary objective of this study is to establish the maximum tolerated dose MTD that can be delivered with a single or few up to 5 fractions of SBRT in inoperable patients with BC
Detailed Description:
SBRT will be performed using appropriate LINACs Truebeam Varian Palo Alto US or Cyberknife Accuray Morges Switzerland with a volumetric arc technique VMAT or non-coplanal technique depending on the treating device The medical devices have a CE certification and will be used in the trial as stated in the CE-marked instructions for use
The gross tumor volume GTV as visualized on computed tomography CT within clipsfiducials when present with a 1mm Cyberknife- 3mm TrueBeam isotropic margin will be treated with an adaptive fractionation depending on its total volume within 13 or 5 fractions An elective volume of 2 cm around the GTV clinical target volume CTV plus a 1mm Cyberknife- 3mm TrueBeam isotropic margin will be treated at constant doses by fractionation cohort These planning target volumes PTVs will be cropped at 5mm to skin and chest wall The principle of irradiating an elective volume around the GTV will be used in this study as done by Vasmel et al 3 This is decided because uncertainties do exist concerning true micro- and macrometastatic extension around the tumor as visualized in the CT and delineation of the tumor on injected CT scans is not expected to be sufficient for coverage of macro and micrometastatic disease Breast MRI is concordant to tumor size as evaluated in pathology within 05 cm for 53 of patients 4 Organs at risk will be defined according to international guidelines 5
Enrolment will be performed within 1-8 weeks after discussion in the HUG Breast Cancer Multidisciplinary Tumor Board MTB
All patients diagnosed with BC in our Institution presenting the aforementioned characteristics are candidates for screening for participation in the study and will be offered clip placement when feasible during diagnostic biopsy by the specialized radiologist Screening criteria will be assessed by the radiologist and radiation oncologist at the time of diagnostic biopsy
Pre-screened patients will be discussed at the Institutional BC MTB Eligible patients will be considered for the study
Treatment procedures Treatment planning Treatment planning will be performed using appropriate TPS Eclipse Varian Palo Alto US or Accuray Precision with relevant techniques of SBRT in order to provide dose-delivery optimizations respecting predefined criteria for target coverage and normal-tissue constraints
Accuracy issues Accuracy of target volume delineation and dose delivery are of outmost importance for both tumor control and toxicity avoidance given the limited number of fractions delivered Accuracy issues are further detailed in the protocol section 341
Quality assurance A quality assurance QA program accompanies this trial consisting of review of treatment plans by the trial medical physicist and the coordinating investigator
SBRT fractionation will be adapted to PTV-GTV and PTV-CTV final volumes With increasing volumes more fractions will be used according to the algorithm presented below representing the dose-adapted fractionation regimens SBRT will be delivered with isoeffective doses a single fraction of 21 23 or 25 Gy on day 1 or in three fractions of 11 13 or 14 Gyfraction on days 1 3 and 5 or in five fractions of 8 or 9 or 10 Gyfraction on days 1 3 5 7 and 9 Dose per adaptive regimen will be escalated every three patients if no DLT appears
In addition patients will undergo physical exams at each study visit and Serious Adverse Events SAEs will be recorded Questionnaires will be given to patients at selected study visits to assess Quality of Life QoL Other study procedures include measure of vital signs ECOG performance status and record of concomitant treatments and procedures at each study visit
The gross tumor volume GTV as visualized on computed tomography CT within clipsfiducials when present with a 1mm Cyberknife- 3mm TrueBeam isotropic margin will be treated with an adaptive fractionation depending on its total volume within 13 or 5 fractions An elective volume of 2 cm around the GTV clinical target volume CTV plus a 1mm Cyberknife- 3mm TrueBeam isotropic margin will be treated at constant doses by fractionation cohort These planning target volumes PTVs will be cropped at 5mm to skin and chest wall The principle of irradiating an elective volume around the GTV will be used in this study as done by Vasmel et al 3 This is decided because uncertainties do exist concerning true micro- and macrometastatic extension around the tumor as visualized in the CT and delineation of the tumor on injected CT scans is not expected to be sufficient for coverage of macro and micrometastatic disease Breast MRI is concordant to tumor size as evaluated in pathology within 05 cm for 53 of patients 4 Organs at risk will be defined according to international guidelines 5
Enrolment will be performed within 1-8 weeks after discussion in the HUG Breast Cancer Multidisciplinary Tumor Board MTB
All patients diagnosed with BC in our Institution presenting the aforementioned characteristics are candidates for screening for participation in the study and will be offered clip placement when feasible during diagnostic biopsy by the specialized radiologist Screening criteria will be assessed by the radiologist and radiation oncologist at the time of diagnostic biopsy
Pre-screened patients will be discussed at the Institutional BC MTB Eligible patients will be considered for the study
Treatment procedures Treatment planning Treatment planning will be performed using appropriate TPS Eclipse Varian Palo Alto US or Accuray Precision with relevant techniques of SBRT in order to provide dose-delivery optimizations respecting predefined criteria for target coverage and normal-tissue constraints
Accuracy issues Accuracy of target volume delineation and dose delivery are of outmost importance for both tumor control and toxicity avoidance given the limited number of fractions delivered Accuracy issues are further detailed in the protocol section 341
Quality assurance A quality assurance QA program accompanies this trial consisting of review of treatment plans by the trial medical physicist and the coordinating investigator
SBRT fractionation will be adapted to PTV-GTV and PTV-CTV final volumes With increasing volumes more fractions will be used according to the algorithm presented below representing the dose-adapted fractionation regimens SBRT will be delivered with isoeffective doses a single fraction of 21 23 or 25 Gy on day 1 or in three fractions of 11 13 or 14 Gyfraction on days 1 3 and 5 or in five fractions of 8 or 9 or 10 Gyfraction on days 1 3 5 7 and 9 Dose per adaptive regimen will be escalated every three patients if no DLT appears
In addition patients will undergo physical exams at each study visit and Serious Adverse Events SAEs will be recorded Questionnaires will be given to patients at selected study visits to assess Quality of Life QoL Other study procedures include measure of vital signs ECOG performance status and record of concomitant treatments and procedures at each study visit
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