Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-27 @ 12:38 PM
Study NCT ID:
NCT00807066
Status:
COMPLETED
Last Update Posted:
2012-04-23
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Gefitinib Trial
Sponsor:
Fondazione Humanitas per la Ricerca
Organization:
Study Overview
Official Title:
Multicentric Randomized Phase III Study Comparing Gefitinib Versus Platinum-Based Chemotherapy In EGFR Fish Positive NSCLC Patients (Range)
Status:
COMPLETED
Status Verified Date:
2010-10
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:
RANGE
Brief Summary:
Patients with locally advanced (IIIB with effusion) or metastatic non-small cell lung cancer (NSCLC), EGFR FISH positive, candidate for a first-line platinum-based chemotherapy will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all eligible patients will be randomized to receive standard chemotherapy (control arm) or gefitinib (250 mg daily dose-experimental arm). Before, and in every case, no more than 4 weeks before study entry, all eligible patients will receive a complete disease staging, including thoracic and abdominal CT-scan, and blood sampling. Bronchoscopy will be done if not previously performed. Bone scan and brain CT-scan will be performed only if clinically indicated. Disease assessment will be performed every 6 weeks (every 2 cycles) for the first 6 cycles, and thereafter every 3 months, with a confirmatory evaluation in all patients with response or disease stabilization no less than 4 weeks after the response assessment, according to RECIST Criteria. A complete disease staging, including the above mentioned procedures, will be performed in case of progressive disease, and, in every cases, when patient withdrawals the trial. Following completion of protocol therapy, patients will be followed every 3 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: