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Randomized Gefitinib Trial

NCT00807066 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2012-04-23

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Gefitinib

Gefitinib 250 mg/day

DRUG

Platinum

Platinum based chemotherapy with cycles every 21 days

Sponsors & Collaborators

  • Fondazione Humanitas per la Ricerca

    lead OTHER

Principal Investigators

  • Armando Santoro, MD · Fondazione Humanitas per la Ricerca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-11-30
Completion
2010-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00807066 on ClinicalTrials.gov