Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-01-31 @ 9:38 PM
Study NCT ID:
NCT00535795
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2007-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-24', 'lastUpdatePostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and efficacy', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA', 'detailedDescription': "It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with nasopharyngeal Carcinoma\n\nExclusion Criteria:\n\n* Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA'}, 'identificationModule': {'nctId': 'NCT00535795', 'briefTitle': 'Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA', 'orgStudyIdInfo': {'id': 'RAC#0971-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week.', 'interventionNames': ['Radiation: Radiation Therapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week.', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Radiation Therapy', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'KFSH&RC', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Nasser Al Rajhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KFSH&RC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}