Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153803
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2005-09-07
Brief Title:
Erlotinib or Placebo Following Chemoradiotherapy ChemoRT in Stage III Non-Small Cell Lung Cancer NSCLC
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel Carboplatin and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer D0410
Status:
COMPLETED
Status Verified Date:
2019-09
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:
None
Brief Summary:
This is a national randomized web-based double-blind study to determine whether erlotinib Tarceva compared to placebo improves progression-free survival PFS for patients with inoperable stage III NSCLC following concurrent docetaxel carboplatin and thoracic radiotherapy We hypothesize that the introduction of this orally active well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40 10 months 14 months
Detailed Description:
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer Based on these data erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation Although a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients
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