Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00617656
Status:
TERMINATED
Last Update Posted:
2024-01-30
First Post:
2008-02-05
Brief Title:
Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma
Sponsor:
Spanish Lung Cancer Group
Organization:
Spanish Lung Cancer Group
Study Overview
Official Title:
Multicenter Phase III Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No safety reasons Interim analysis shows that the hypothesis superiority of the experimental arm over the control arm- would not be confirmed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREC
Brief Summary:
Primary objective
Progression free survival
Secondary objectives
Assess Overall survival of both treatment groups
Assess Tumor response rate using RECIST criteria
Assess Toxicity profile of patients enrolled in the study
Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy
Progression free survival
Secondary objectives
Assess Overall survival of both treatment groups
Assess Tumor response rate using RECIST criteria
Assess Toxicity profile of patients enrolled in the study
Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy
Detailed Description:
Study population
Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status ECOG 0-1 and measurable disease at least one target lesion according to RECIST criteria
Duration of treatment
Six chemotherapy cycles will be given The duration of every cycle will be 21 days If the treatment is beneficial it may be prolonged to a total of 8 cycles at the discretion of the investigator
Calendar and planned finalization date
The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up
Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status ECOG 0-1 and measurable disease at least one target lesion according to RECIST criteria
Duration of treatment
Six chemotherapy cycles will be given The duration of every cycle will be 21 days If the treatment is beneficial it may be prolonged to a total of 8 cycles at the discretion of the investigator
Calendar and planned finalization date
The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-004278-20 | EUDRACT_NUMBER | None | None |