Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-29
Brief Title:
Radiotherapy Treatment Planning Comparison Using SBRT-PATHY Photons Versus CARBON-PATHY for Unresectable Bulky Tumors
Sponsor:
EBG MedAustron GmbH
Organization:
EBG MedAustron GmbH
Study Overview
Official Title:
Radiotherapy Treatment Planning Comparison Using SBRT-PATHY Photons Versus CARBON-PATHY for Unresectable Bulky Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
S-C-PATHY
Brief Summary:
This study uses a novel unconventional radiotherapy technique consisting of high dose PArtial Tumor irradiation targeting exclusively the HYpoxic segment of unresectable bulky tumors delivered either with photons SBRT-PATHY or with carbon-ions CARBON-PATHY while sparing the peritumoral immune microenvironment PIM
Detailed Description:
This study will be conducted as a two phase study Phase A is a retrospective study Up to 10 patients with bulky 6cm tumors previous planned with planning CT with IV contrast will be selected for planning and dosimetry comparison This is performed to optimize the contouring and planning procedures Phase B is a prospective study Ten patients with bulky 6cm tumor requiring radiotherapy with planning CT and MR with IV contrast will be accrued Every effort will be made to include equal numbers of patients 2-3 from head and neck thorax abdomen and pelvis Their images will be used for planning and dosimetry comparison
Patients will be treated according to clinical plans The study plans will not be used for treatment Treatment plans for Photon delivery SBRT-PATHY and Carbon delivery CARBON-PATHY to deliver 30 Gy in three fractions will be planned to be delivered to the BTV will be performed SBRT-PATHY plans will be generated at the Princess Margaret Cancer Center PMCC Toronto Canada while CARBON-PATHY plans will be generated at the MedAustron Center for Particle Therapy and Research W Neustadt Austria
The objective is to compare the dosimetric profile achievable using SBRT-PATHY using photons and CARBON-PATHY using carbon-ions for unresectable bulky tumors and surrounding tissues
Patients will be treated according to clinical plans The study plans will not be used for treatment Treatment plans for Photon delivery SBRT-PATHY and Carbon delivery CARBON-PATHY to deliver 30 Gy in three fractions will be planned to be delivered to the BTV will be performed SBRT-PATHY plans will be generated at the Princess Margaret Cancer Center PMCC Toronto Canada while CARBON-PATHY plans will be generated at the MedAustron Center for Particle Therapy and Research W Neustadt Austria
The objective is to compare the dosimetric profile achievable using SBRT-PATHY using photons and CARBON-PATHY using carbon-ions for unresectable bulky tumors and surrounding tissues
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