Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT00239304
Status:
COMPLETED
Last Update Posted:
2007-12-18
First Post:
2005-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-14', 'studyFirstSubmitDate': '2005-10-13', 'studyFirstSubmitQcDate': '2005-10-13', 'lastUpdatePostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parts 1 and 2: Safety (Incidence of DLTs)'}, {'measure': 'Part 3: Safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)'}, {'measure': 'Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels'}]}, 'conditionsModule': {'keywords': ['Stage III Head and Neck Cancer', 'Stage IV Head and Neck Cancer'], 'conditions': ['Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': 'To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed head and neck cancer\n* Lymph node negative or positive\n* Metastasis negative\n* Chemo- and radiotherapy naïve\n* WHO 0-2\n* Measurable disease by RECIST\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe alcohol abuse\n* Active ILD\n* Co-existing chronic gastrointestinal disease(s)\n* Brain metastasis'}, 'identificationModule': {'nctId': 'NCT00239304', 'briefTitle': 'Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': '1839IL/0151'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gefitinib', 'type': 'DRUG'}, {'name': 'Cisplatin', 'type': 'DRUG'}, {'name': 'Radiotherapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Research Centre', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'AstraZeneca Finland Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}