Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00801736
Status:
TERMINATED
Last Update Posted:
2013-12-10
First Post:
2008-12-02
Brief Title:
ERCC1 Targeted Trial
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Multicentre Randomised Phase III Trial of Platinum-based Chemotherapy Versus Non-platinum Chemotherapy After ERCC1 Stratification in Patients With AdvancedMetastatic Non-small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The antibody used did not appear prognosticpredictive based on interim results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ET
Brief Summary:
Lung cancer is the leading cause of cancer death in the UK leading to 34 000 deaths each year 22 of cancer deaths Non-small cell lung cancer NSCLC is the most common histology accounting for approximately 80 of cases and most present with advanced stage IIIb or IV disease The recommended treatment for advanced disease is a doublet platinum-based chemotherapy although the survival benefits are modest Even among those fit enough for chemotherapy the response rate is only 20-40 and median survival averages 9-10 months with the newer platinum-containing chemotherapy regimen Schiller et al 2002 Rudd et al 2005 Lee et al 2007 Only 11 of patients went on to survive 2 years when treated with the newer gemcitabinecarboplatin regimen established by the London Lung Cancer Group Rudd et al 2005 Lee et al 2007 New strategies are needed to further improve the prognosis of this disease
Detailed Description:
TRIAL OBJECTIVES
Primary objective
The trial will have two main objectives
To detect an improvement in survival for ERCC1ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment
To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment
Secondary objectives
To examine progression-free survival response rate and quality of life between the two treatment regimens according to ERCC1 status
To investigate whether the treatment effect differs according to histology squamous vs nonsquamousgender males vs females performance status
To undertake a cost-effectiveness analysis based on all patients and according to ERCC1 status
Primary objective
The trial will have two main objectives
To detect an improvement in survival for ERCC1ve patients treated with a non-platinum chemotherapy compared to platinum-based treatment
To establish non-inferiority or improvement in survival for ERCC1-ve patients treated with a platinum-based chemotherapy compared to non-platinum treatment
Secondary objectives
To examine progression-free survival response rate and quality of life between the two treatment regimens according to ERCC1 status
To investigate whether the treatment effect differs according to histology squamous vs nonsquamousgender males vs females performance status
To undertake a cost-effectiveness analysis based on all patients and according to ERCC1 status
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2007-007639-17 | None | None | None |
| CRUK-UCL-ET | None | None | None |