Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500481
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis RADIATE-LM Trial
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis RADIATE-LM
Status:
NOT_YET_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 proton craniospinal irradiation pCSI to involved-field radiation therapy IFRT for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord leptomeningeal metastasis Patients with leptomeningeal metastasis LM may develop multiple areas of nervous system neurologic impairment that can be life-threatening Radiation therapy RT effectively relieves local symptoms due to LM RT uses high energy radiography x-rays particles or radioactive seeds to kill cancer cells and shrink tumors IFRT is commonly used to treat symptoms of LM IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve andor prevent symptoms pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid CSF brain and spinal cord The pCSI treatment could delay the worsening of LM Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To compare overall survival OS between proton craniospinal irradiation pCSI and involved-field radiotherapy IFRT in patients with breast cancer or non-small cell lung cancer NSCLC leptomeningeal metastasis
SECONDARY OBJECTIVES
I To compare central nervous system progression-free survival CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis
II To compare time to CNS progression between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis
III To compare CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis as evaluated by central review of imaging
IV To compare the rate of radiation-induced central nervous system necrosis between pCSI versus vs IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis
V To characterize treatment-related adverse events using Common Terminology Criteria for Adverse Events CTCAE version v 50
VI To compare patient-reported outcomes symptoms severity subscale per MD Anderson Symptom Inventory for Brain Tumors MDASI-BT and MD Anderson Symptom Inventory for Spine Tumors MDASI-SP in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
EXPLORATORY OBJECTIVE
I To compare patient-reported outcomes symptoms interference brain tumor-specific spine tumor-specific subscales per MDASI-BT and MDASI-SP in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients undergo involved-field radiation therapy delivered to specific areas of LM that are causing andor may cause symptoms 5 days a week for a total of 10 days of treatment in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or positron emission tomography PETCT during screening and magnetic resonance imaging MRI as well as possible lumbar puncture LP throughout the study Patients may optionally undergo research blood sample and CSF collection throughout the study
ARM 2 Patients undergo pCSI radiation therapy delivered to the entire space containing the CSF brain and spinal cord 5 days a week for a total of 10 days of treatment in the absence of disease progression or unacceptable toxicity Patients undergo CT or PETCT during screening and MRI as well as possible LP throughout the study Patients may optionally undergo research blood sample and CSF collection throughout the study
After completion of study treatment patients are followed every 3 months for 12 months and then every 6 months for up to 3 years from end of RT
I To compare overall survival OS between proton craniospinal irradiation pCSI and involved-field radiotherapy IFRT in patients with breast cancer or non-small cell lung cancer NSCLC leptomeningeal metastasis
SECONDARY OBJECTIVES
I To compare central nervous system progression-free survival CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis
II To compare time to CNS progression between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis
III To compare CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis as evaluated by central review of imaging
IV To compare the rate of radiation-induced central nervous system necrosis between pCSI versus vs IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis
V To characterize treatment-related adverse events using Common Terminology Criteria for Adverse Events CTCAE version v 50
VI To compare patient-reported outcomes symptoms severity subscale per MD Anderson Symptom Inventory for Brain Tumors MDASI-BT and MD Anderson Symptom Inventory for Spine Tumors MDASI-SP in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
EXPLORATORY OBJECTIVE
I To compare patient-reported outcomes symptoms interference brain tumor-specific spine tumor-specific subscales per MDASI-BT and MDASI-SP in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients undergo involved-field radiation therapy delivered to specific areas of LM that are causing andor may cause symptoms 5 days a week for a total of 10 days of treatment in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT or positron emission tomography PETCT during screening and magnetic resonance imaging MRI as well as possible lumbar puncture LP throughout the study Patients may optionally undergo research blood sample and CSF collection throughout the study
ARM 2 Patients undergo pCSI radiation therapy delivered to the entire space containing the CSF brain and spinal cord 5 days a week for a total of 10 days of treatment in the absence of disease progression or unacceptable toxicity Patients undergo CT or PETCT during screening and MRI as well as possible LP throughout the study Patients may optionally undergo research blood sample and CSF collection throughout the study
After completion of study treatment patients are followed every 3 months for 12 months and then every 6 months for up to 3 years from end of RT
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-2024-04895 | REGISTRY | None | None |
| NRG-BN014 | OTHER | None | None |
| NRG-BN014 | OTHER | None | None |
| U10CA180868 | NIH | None | None |