Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431685
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-19
Brief Title:
Safety and Efficacy of Whole Brain LDRTICIIntrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer
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:
This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy WB-LDRT combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer
Detailed Description:
This exploratory phase I study will be conducted in West China Hospital Sichuan University Three cohorts of whole brain low dose radiotherapy 3 patients per cohort will be enrolled to determine the safety and efficacy of whole brain low dose radiotherapy combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer
Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with WB-LDRT at same dose 4 Gy2f with diffent cycles decried as below PD-1 inhibitor pemetrexed chemotherapy and intrathecal pemetrexed every 3 weeks Q3w for 4 cycles
Patients will receive WB-LDRT at 3 cohorts with increasing dose fractions 4 Gy2f of one cycle in group 1 4 Gy2f of two cycles in group 2 4 Gy2f of four cycles in group 3
Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with WB-LDRT at same dose 4 Gy2f with diffent cycles decried as below PD-1 inhibitor pemetrexed chemotherapy and intrathecal pemetrexed every 3 weeks Q3w for 4 cycles
Patients will receive WB-LDRT at 3 cohorts with increasing dose fractions 4 Gy2f of one cycle in group 1 4 Gy2f of two cycles in group 2 4 Gy2f of four cycles in group 3
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