Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500455
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
Phase III Trial of Single Fraction Stereotactic Radiosurgery SRS Versus Fractionated SRS FSRS for Intact Brain Metastases
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery FSRS to usual care stereotactic radiosurgery SRS in treating patients with cancer that has spread from where it first started to the brain Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors FSRS delivers a high dose of radiation to the tumor over 3 treatments SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain
Detailed Description:
PRIMARY OBJECTIVE
I To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact ie unresected brain metastases
SECONDARY OBJECTIVES
I To compare time to intracranial progression-free survival between FSRS and SRS
II To compare overall survival between FSRS and SRS III To determine if the time to local failure is improved with FSRS compared to SRS as evaluated by central review of imaging
IV To evaluate if there is any difference in central nervous system CNS failure patterns local versus vs distant brain failure vs both in patients who receive FSRS compared to patients who receive SRS
V To compare the rates of radiation necrosis in patients who receive FSRS vs SRS
VI To compare the time to salvage whole brain radiation therapy WBRT between patients who receive FSRS and those who receive SRS
VII To compare the rates of post-treatment adverse events associated with FSRS and SRS
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo SRS over 30-90 minutes for 1 fraction on study Additionally patients undergo computed tomography CT and magnetic resonance imaging MRI on study
ARM II Patients undergo FSRS over 30-90 minutes for 3 fractions on study Additionally patients undergo CT and MRI on study
After completion of study treatment patients are followed up every 3 months for 1 year every 4 months for 1 year then every 6 months for 3 years
I To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact ie unresected brain metastases
SECONDARY OBJECTIVES
I To compare time to intracranial progression-free survival between FSRS and SRS
II To compare overall survival between FSRS and SRS III To determine if the time to local failure is improved with FSRS compared to SRS as evaluated by central review of imaging
IV To evaluate if there is any difference in central nervous system CNS failure patterns local versus vs distant brain failure vs both in patients who receive FSRS compared to patients who receive SRS
V To compare the rates of radiation necrosis in patients who receive FSRS vs SRS
VI To compare the time to salvage whole brain radiation therapy WBRT between patients who receive FSRS and those who receive SRS
VII To compare the rates of post-treatment adverse events associated with FSRS and SRS
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients undergo SRS over 30-90 minutes for 1 fraction on study Additionally patients undergo computed tomography CT and magnetic resonance imaging MRI on study
ARM II Patients undergo FSRS over 30-90 minutes for 3 fractions on study Additionally patients undergo CT and MRI on study
After completion of study treatment patients are followed up every 3 months for 1 year every 4 months for 1 year then every 6 months for 3 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04812 | REGISTRY | None | None |
| NRG-BN013 | OTHER | None | None |
| NRG-BN013 | OTHER | None | None |
| U10CA180868 | NIH | None | None |