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Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234468
Recruitment Status : Terminated (Closed due to insufficient recruitment)
First Posted : October 7, 2005
Last Update Posted : May 20, 2011
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Brief Summary:
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Carcinoma Drug: Iressa (Gefitinib) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy
Study Start Date : January 2004
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Primary Outcome Measures :
  1. Time to progression (2 years after Last patient in)

Secondary Outcome Measures :
  1. Modalities of relapse or progression (2 years after Last patient in)
  2. Overall survival (2 years after Last patient in)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically Confirmed Non Small Cell Lung Cancer.
  • Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
  • Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
  • Response to combined therapy

Exclusion Criteria:

  • No previous treatment with ZD1839 or any other EGFR-targeted therapy
  • No progressive disease after combined therapy for locally advanced NSCLC
  • No presence of metastatic disease
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity from previous anticancer therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234468

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Research Site
Avellino, Italy
Research Site
Bergamo, Italy
Research Site
Bologna, Italy
Research Site
Cagliari, Italy
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Campobasso, Italy
Research Site
Catania, Italy
Research Site
Catanzaro, Italy
Research Site
Chieti, Italy
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Cosenza, Italy
Research Site
Della Fratte, Italy
Research Site
Emilia, Italy
Research Site
Fano, Italy
Research Site
Firenze, Italy
Research Site
Forli, Italy
Research Site
Frattamaggiore, Italy
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Livorno, Italy
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Messina, Italy
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Milano, Italy
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Napoli, Italy
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Novara, Italy
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Orbassano, Italy
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Padova, Italy
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Palermo, Italy
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Pavia, Italy
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Potenza, Italy
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Ravenna, Italy
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Rimini, Italy
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Roma, Italy
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San Giovanni Rotondo, Italy
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Sassari, Italy
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Taormina, Italy
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Venezia-Mestre, Italy
Sponsors and Collaborators
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Principal Investigator: Lucio Crino, MD Bologna Italy

Layout table for additonal information Identifier: NCT00234468     History of Changes
Other Study ID Numbers: 1839IL/0126
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: May 2011
Keywords provided by AstraZeneca:
Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action