Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 5:54 AM
Study NCT ID:
NCT00963404
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2009-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image-Guided Tumorboost of Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2009-08-20', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tumor control', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Acute and late adverse effects of the radiotherapy treatment', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Image-guided Radiotherapy', 'Fiducial marker', 'Adverse effects'], 'conditions': ['Bladder Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cirro.dk', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Muscle invasive bladder cancer (transitional carcinoma)\n* Unifocal\n* TNM stage T2a-4a, N0-1, M0\n* unfit for radical cystectomy\n\nExclusion Criteria:\n\n* Hyperthyroidism\n* Multinodular goiter\n* Pregnancy\n* Breast feeding\n* WHO preformance status more than 2\n* Iodine allergy\n* MRI or CT contrast media allergy\n* Bi-lateral hip-prosthesis'}, 'identificationModule': {'nctId': 'NCT00963404', 'briefTitle': 'Image-Guided Tumorboost of Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study', 'orgStudyIdInfo': {'id': 'CIRRO IP 070109 DaBlaCa-1'}, 'secondaryIdInfos': [{'id': 'M-20080210'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tumor-boost', 'description': 'Image-guided tumorboost of the bladder cancer.', 'interventionNames': ['Radiation: Radiation boost']}], 'interventions': [{'name': 'Radiation boost', 'type': 'RADIATION', 'description': 'Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.', 'armGroupLabels': ['Tumor-boost']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Dk-8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'The department of Oncology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': 'Dk-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'The department of Oncology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'Dk-2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'The department of Oncology, Herlev University Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': 'Dk-5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'The department of Oncology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jimmi Sondergaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The department of Oncology, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}