Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05236946
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2022-02-01
Brief Title:
Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM A Phase III RCT
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases A Phase III Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-04
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:
Tyrosine Kinase Inhibitors TKIs especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases Brain radiotherapysurgery is the standard treatment in brain metastases especially symptomatic metastases however the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IEC3470 | OTHER | Tata Memorial Hospital | None |