Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-04 @ 3:46 AM
Study NCT ID:
NCT00617656
Status:
TERMINATED
Last Update Posted:
2024-01-30
First Post:
2008-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma
Sponsor:
Spanish Lung Cancer Group
Organization:
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:
ยท 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.
ยท 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-004278-20 | EUDRACT_NUMBER | None | View |