Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373425
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2006-09-07
Brief Title:
A Study of Erlotinib Tarceva After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma NSCLC Patients Who Have Epidermal Growth Factor Receptor EGFR Positive Tumors
Sponsor:
OSI Pharmaceuticals
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Phase 3 Study of Single-agent Tarceva Erlotinib Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors
Status:
COMPLETED
Status Verified Date:
2015-09
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:
RADIANT
Brief Summary:
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients
Detailed Description:
After the initiation of the study the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once Since the integrity of the data from these patients was seriously compromised these patients were considered unevaluable for the protocol-specified analyses These participants are referred to as the breached protocol cohort BPC and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years including posttreatment and long-term follow-up assessments not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment or withdrawing consent from treatment and further assessments Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analysesThe sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately
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 |
|---|---|---|---|
| 2005-001747-29 | EUDRACT_NUMBER | None | None |