Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT00234468
Status:
TERMINATED
Last Update Posted:
2011-05-20
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 490}}, 'statusModule': {'whyStopped': 'Closed due to insufficient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-19', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression (2 years after Last patient in)'}], 'secondaryOutcomes': [{'measure': 'Modalities of relapse or progression (2 years after Last patient in)'}, {'measure': 'Overall survival (2 years after Last patient in)'}]}, 'conditionsModule': {'keywords': ['Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)'], 'conditions': ['Non Small Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically Confirmed Non Small Cell Lung Cancer.\n* Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).\n* Chemotherapy with regimens containing cisplatin or carboplatin is mandatory\n* Response to combined therapy\n\nExclusion Criteria:\n\n* No previous treatment with ZD1839 or any other EGFR-targeted therapy\n* No progressive disease after combined therapy for locally advanced NSCLC\n* No presence of metastatic disease\n* 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\n* Any unresolved chronic toxicity from previous anticancer therapy.'}, 'identificationModule': {'nctId': 'NCT00234468', 'briefTitle': 'Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1839IL/0126'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Iressa (Gefitinib)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avellino', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Campobasso', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Chieti', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Cosenza', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'city': 'Della Fratte', 'country': 'Italy', 'facility': 'Research Site'}, {'city': 'Emilia', 'country': 'Italy', 'facility': 'Research Site'}, {'city': 'Fano', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 43.84052, 'lon': 13.01665}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Forlì', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'city': 'Frattamaggiore', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.9414, 'lon': 14.27588}}, {'city': 'Livorno', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Orbassano', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Potenza', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'city': 'Ravenna', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'city': 'Rimini', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Giovanni Rotondo', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Sassari', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'city': 'Taormina', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 37.85358, 'lon': 15.28851}}, {'city': 'Venezia-Mestre', 'country': 'Italy', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Lucio Crino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bologna Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}