Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829019
Status:
RECRUITING
Last Update Posted:
2021-04-02
First Post:
2021-03-31
Brief Title:
Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib WBI
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Randomised Controlled Trial to Investigate the Neurocognition in EGFR-mutant Advanced Non-small Cell Lung Cancer Patients With Symptomatic Brain Metastases Treated With Osimertinib or Osimertinib Plus Whole-brain Irradiation WBI
Status:
RECRUITING
Status Verified Date:
2021-03
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 is a prospective randomised positive-controlled study to assess the neurocognitive function of upfront Osimertinib compared to whole-brain irradiation WBI plus Osimertinib in EGFR-mutant Ex 19Del and L858R NSCLC patients with symptomatic brain metastases as well as the efficacy and safety
Detailed Description:
Account for patients with wild type EGFR sample attrition incidence rate of symptomatic brain metastasis10 and any other reasons for screen failure rate50 it is esimated that 88 patients will be randomized from 5 sites Patients will be randomized 11 the experimental arm is upfront Osimertinib with WBI sequential therapy while the control arm is Osimertinib plus WBI Osimertinib at a dose of 80 mg once per day until unacceptable adverse events or disease progression occurred WBI could be given to patients in experimental arm at any time base on investigators decision after treatment initiated Patients will be stratifed at randomization by GPA score 35-4 vs 35 and the mutation type Ex19Del L858R Patients will undergo the neurocognition efficacy and safety assessments at baseline and every 8 weeks until treatment is completed or discontinued About time to brain metastases symptoms deterioration the assessment was repeated in the first week on site second week through telephone and fourth week on site The rest assessment will be as well as other evaluations repeated every 8 weeks To evaluate the correlation and predictive or prognostic value between gene dynamic changes and clinical efficacy the tissue plasma and cerebrospinal fluid CSF samples will be collected at baseline CSF will be collected in patients with intracranial progression Plasma will be collected in all the patients at disease progression while tissue is optional Also plasma will be collected at week 8first evaluation of efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None