Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT04155034
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)
Status:
RECRUITING
Status Verified Date:
2025-05
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:
This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.
II. To compare brain-metastasis-free survival between the arms. III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease.
IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.
V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.
VI. To compare the frequency and severity of toxicities between the two arms.
ADDITIONAL OBJECTIVE:
I. To collect blood for banking.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
I. To evaluate whether overall survival (OS) with magnetic resonance imaging (MRI) surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
I. To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms.
II. To compare brain-metastasis-free survival between the arms. III. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease.
IV. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms.
V. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms.
VI. To compare the frequency and severity of toxicities between the two arms.
ADDITIONAL OBJECTIVE:
I. To collect blood for banking.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo conventional or hippocampal avoidance PCI over 20 minutes 5 days per week for 2 weeks. Patients also undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
ARM II: Patients undergo MRI scan at 3, 6, 9, 12, 18, and 24 months.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-05338 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| S1827 | OTHER | SWOG | View | |
| S1827 | OTHER | CTEP | View | |
| U10CA180888 | NIH | None | https://reporter.nih.gov/quic… | View |