Ignite Creation Date:
2024-05-06 @ 12:32 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01603849
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2012-04-17
Brief Title:
Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
Randomized Phase II Trial of Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma Clinical Stage IIIB and IV With High Risk of Brain Metastasis
Status:
COMPLETED
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:
PCI
Brief Summary:
Lung cancer is the first cause of death among cancer patients Non Small Cell lung cancer NSCLS represents about 80-85 of the cases Of this about 80 presents with locally advanced or metastatic disease Important to mention the number of patients that progress or recur in central nervous system CNS It has been reported that patients with adenocarcinoma who are under 60 years and with elevated carcinoembryonic antigen CEA are in the highest risk to develop brain metastasis In small cell lung cancer treatment with prophylactic cranial irradiation PCI is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival OS and progression free survival PFS However in NSCLC PCI has not been able to prove any survival benefit only in CNS PFS probably because there is no trial to our knowledge of PCI in NSCLC that include only the specific group of patients considered in high risk of developing brain metastasis
Detailed Description:
Objectives
1 To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after locoregional or systemic treatment
2 Evaluate the benefit in OS in the specific group of patients who are at increased risk of developing brain metastasis
3 Evaluate quality of life and mental function before and after treatment with PCI and compare it with patients in the observation group
Methods One hundred and twenty eight patients with locally advanced or metastatic except CNS metastasis NSCLC will be included and randomized to receive either observation or PCI 25 Gy in 10 fractions Whole Brain Radiotherapy WBRT once the initial treatment has been completed and progression of the disease ruled out
1 To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after locoregional or systemic treatment
2 Evaluate the benefit in OS in the specific group of patients who are at increased risk of developing brain metastasis
3 Evaluate quality of life and mental function before and after treatment with PCI and compare it with patients in the observation group
Methods One hundred and twenty eight patients with locally advanced or metastatic except CNS metastasis NSCLC will be included and randomized to receive either observation or PCI 25 Gy in 10 fractions Whole Brain Radiotherapy WBRT once the initial treatment has been completed and progression of the disease ruled out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None