Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-31 @ 4:33 PM
Study NCT ID:
NCT00681967
Status:
COMPLETED
Last Update Posted:
2010-09-23
First Post:
2008-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for 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'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-21', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa'}], 'secondaryOutcomes': [{'measure': 'Both cohorts overall survival (OS) local control (LC) rate at six months and at one year'}, {'measure': 'Cohort 1 only time-to-recurrence (TTR)'}, {'measure': 'Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['squamous cell cancer of the head & neck', 'Gefitinib', 'IRESSA', 'EGFR Inhibitor', 'EGFR-tyrosine kinase inhibitor', 'Subjects with histologically proven squamous cell cancer of the head & neck', 'Cohort 1:qualifying for postoperative radiotherapy', '(pT3, pT4, pN2b, pN2c, pN3).', 'Cohort 2:qualifying for definite chemoradiotherapy', '(Lateral oropharynx, tonsils: T1N2b-3, T2N1-3, T3any N;', 'Base of tongue, vallecula: T1N1-3, T2-4 any N; Oral cavity,', 'glottic and supraglottic larynx; Any TN1-3, T3-4 any N;', 'Hypopharynx: T1N1-3, T2-4 and N)'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age over 18 years\n* Histologically proven squamous cell cancer of the head \\& neck (SCCHN)\n* Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3\n\nExclusion Criteria:\n\n* Hypersensitivity to ZD1839 or any of the excipients of this product\n* Tumour stage M1\n* Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ\n* Absolute neutrophil counts \\<1.5 x 109'}, 'identificationModule': {'nctId': 'NCT00681967', 'acronym': 'IRESSA&H&N', 'briefTitle': 'Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial', 'orgStudyIdInfo': {'id': '1839IL/0525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'post operative combination of gefinib and RT', 'interventionNames': ['Drug: Gefitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'combination of gefitinib with RT and Chemotherapy in non operated patients', 'interventionNames': ['Drug: Gefitinib']}], 'interventions': [{'name': 'Gefitinib', 'type': 'DRUG', 'otherNames': ['IRESSA (TM)'], 'description': '250 mg; oral', 'armGroupLabels': ['Cohort 1']}, {'name': 'Gefitinib', 'type': 'DRUG', 'otherNames': ['IRESSA (TM)'], 'description': '250mg; oral', 'armGroupLabels': ['Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Research Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Christoph Rochlitz, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Basel'}, {'name': 'Madeleine Billeter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland'}, {'name': 'Verena Renggli', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. med. Dirk Schneider', 'oldOrganization': 'AstraZeneca AG Switzerland'}}}}