Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT00608751
Status:
TERMINATED
Last Update Posted:
2013-05-24
First Post:
2008-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Lack of accrual and software issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-22', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-01-22', 'lastUpdatePostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)', 'timeFrame': '7 weeks', 'description': 'Feasibility is determined by employing weekly 3D onboard imaging for plan re-evaluation and initiation of an adaptive process if the original PTV and/or normal structure goals are compromised.'}], 'secondaryOutcomes': [{'measure': 'Measure additional time required by physician and ancillary staff for the process of adaptive IMRT', 'timeFrame': '7 weeks', 'description': 'Recording on a weekly basis the actual time required for repeat CT imaging, plan re-evaluation, replanning, and repeat physics QA.'}, {'measure': 'Identify a subset of patients in whom adaptive IMRT would be recommended', 'timeFrame': '7 weeks'}, {'measure': 'Measure acute and late toxicity', 'timeFrame': 'Until patient death'}, {'measure': 'Local, regional, and distant recurrence', 'timeFrame': 'Until recurrence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Newly Diagnosed head and neck cancer'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer', 'detailedDescription': "In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18\n* Karnofsky Performance Status of \\>= 60\n* New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)\n* All stages with measurable gross disease (\\>= 1.0 cm) by CT imaging\n* Pathologic confirmation of squamous cell carcinoma by biopsy or cytology\n* Signed study-specific consent form\n* Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)\n\nExclusion Criteria\n\n* Age \\< 18\n* Karnofsky Performance Status \\< 60\n* Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)\n* Prior radiation therapy to the head-and-neck region'}, 'identificationModule': {'nctId': 'NCT00608751', 'acronym': 'IMRT', 'briefTitle': 'A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer', 'orgStudyIdInfo': {'id': '06-1210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMRT', 'description': 'External beam radiation with 6 MV photons will be delivered in 200 cGy daily fractions, 35 fractions over 7 weeks for a total dose of 7000 cGy.', 'interventionNames': ['Radiation: IMRT']}], 'interventions': [{'name': 'IMRT', 'type': 'RADIATION', 'armGroupLabels': ['IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Wade Thorstad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}