Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436612
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-14
Brief Title:
Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas MARS Trial
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas MARS Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Recent advances in radiation treatment have allowed for higher doses per treatment to be delivered safely This study plans to use an MRI-guided linear accelerator to deliver the radiation treatment to ensure that the radiation dose is administered to the cancerous tumor not the vital body organs
Potential participants with a sarcoma diagnosis will be referred to Radiation Oncology during this study If the participant is interested in participating in this study she receives radiation treatment daily for 5 consecutive days except for weekends and holidays Within 12 weeks of completing the radiation therapy the participant will have the primary tumor surgically removed The radiation oncology team will follow the patients for 5 years after completing radiation therapy
Potential participants with a sarcoma diagnosis will be referred to Radiation Oncology during this study If the participant is interested in participating in this study she receives radiation treatment daily for 5 consecutive days except for weekends and holidays Within 12 weeks of completing the radiation therapy the participant will have the primary tumor surgically removed The radiation oncology team will follow the patients for 5 years after completing radiation therapy
Detailed Description:
Each patient will undergo radiation simulation and planning A custom vac-lok bag alpha cradle or equivalent immobilization device will be used Both CT and MRI simulation will be obtained which is standard of care for any patient undergoing radiation therapy for soft tissue sarcomas
The study investigator will be responsible for delineating the gross tumor volume GTV using the CT as well as MRI performed as part of staging Guidelines for contouring will be as per the currently open NRG trial for sarcomas In general this may entail expansions by 5-15 mm isotropically should include any suspicious areas be identified on T2 weighted MRI and should be cropped to natural anatomic borders This clinical target volume CTV will then be expanded to a planning treatment volume PTV using a 3-5 mm expansion
A prescription dose of 5-6 Gy x 5 fractions 25-30 Gy will be delivered to at least 95 of the PTV Stereotactic body radiotherapy SBRT andor intensity modulated radiotherapy IMRT planning techniques may be used to minimize radiation dose to nearby organs at risk OAR but is not required
Delineation of normal structures will be performed and verified by the responsible study investigator The radiation physicist or dosimetrist will optimize the treatment plan prior to approval for treatment Dose volume histograms DVH and normal tissue constraint parameters specified below will be used to judge the plan quality and optimize PTV coverage with OAR sparing prior to approval
Radiation will be delivered daily for 5 consecutive days with the exception of weekends and holidays In instances where the radiation treatment week contains a holiday or scheduling availability is limited two fractions of radiation may be given on the same day providing that the fractions are administered 6 hours apart this is considered standard of care treatment
Surgical resection of at least the primary tumor will follow within 12 weeks of completing radiation therapy Surgical specimens will be sent to pathology for evaluation and for review by a multidisciplinary tumor board
The study investigator will be responsible for delineating the gross tumor volume GTV using the CT as well as MRI performed as part of staging Guidelines for contouring will be as per the currently open NRG trial for sarcomas In general this may entail expansions by 5-15 mm isotropically should include any suspicious areas be identified on T2 weighted MRI and should be cropped to natural anatomic borders This clinical target volume CTV will then be expanded to a planning treatment volume PTV using a 3-5 mm expansion
A prescription dose of 5-6 Gy x 5 fractions 25-30 Gy will be delivered to at least 95 of the PTV Stereotactic body radiotherapy SBRT andor intensity modulated radiotherapy IMRT planning techniques may be used to minimize radiation dose to nearby organs at risk OAR but is not required
Delineation of normal structures will be performed and verified by the responsible study investigator The radiation physicist or dosimetrist will optimize the treatment plan prior to approval for treatment Dose volume histograms DVH and normal tissue constraint parameters specified below will be used to judge the plan quality and optimize PTV coverage with OAR sparing prior to approval
Radiation will be delivered daily for 5 consecutive days with the exception of weekends and holidays In instances where the radiation treatment week contains a holiday or scheduling availability is limited two fractions of radiation may be given on the same day providing that the fractions are administered 6 hours apart this is considered standard of care treatment
Surgical resection of at least the primary tumor will follow within 12 weeks of completing radiation therapy Surgical specimens will be sent to pathology for evaluation and for review by a multidisciplinary tumor board
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04364 | REGISTRY | Clinical Trials Reporting Program | None |