Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT02976051
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2016-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-18', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loco-regional failure', 'timeFrame': 'Year 3', 'description': 'loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Year 3', 'description': 'Death from all causes'}, {'measure': 'Acute radiation related morbidity', 'timeFrame': 'Month 3'}, {'measure': 'Late radiation related morbidity', 'timeFrame': 'Year 3'}, {'measure': 'Disease-specific death', 'timeFrame': 'Year 3', 'description': 'Disease-specific death is defined as death from or with the cancer in question;'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Locally Advanced Head and Neck Cancer', 'Radiotherapy', 'Hypoxic Radioresistance']}, 'referencesModule': {'references': [{'pmid': '23083497', 'type': 'RESULT', 'citation': 'Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning', 'detailedDescription': 'Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.\n\nInclusion:\n\nPatients must fulfill the following:\n\nPositive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage III-IV larynx, pharynx, oral cavity\n* Hypoxic FAZA-PET positive\n* Indication for primary radio-chemotherapy\n* Informed consent\n\nExclusion Criteria:\n\n* HPV positive oropharynx cancer\n* Primary surgery'}, 'identificationModule': {'nctId': 'NCT02976051', 'briefTitle': 'DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC', 'organization': {'class': 'NETWORK', 'fullName': 'Danish Head and Neck Cancer Group'}, 'officialTitle': 'DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'DAHANCA 33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with HART-CN', 'description': 'HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole', 'interventionNames': ['Radiation: HART-CN']}], 'interventions': [{'name': 'HART-CN', 'type': 'RADIATION', 'description': 'HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole', 'armGroupLabels': ['Treatment with HART-CN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000 C', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jens Overgaard, Prof., MD', 'role': 'CONTACT', 'email': 'jens@oncology.au.dk', 'phone': '+45 7846 2629'}, {'name': 'Mette Saxø, MD', 'role': 'CONTACT', 'email': 'mette.saksoe@oncology.au.dk', 'phone': '+89492619'}], 'facility': 'Department of Experimental Clinical Oncology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Jens Overgaard, MD, DMSc', 'role': 'CONTACT', 'email': 'jens@oncology.au.dk', 'phone': '+45 78462629'}, {'name': 'Mette Saksoe, MD', 'role': 'CONTACT', 'email': 'mette.saksoe@oncology.au.dk', 'phone': '+45 78462629'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Head and Neck Cancer Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD DMSc', 'investigatorFullName': 'Jens Overgaard', 'investigatorAffiliation': 'Danish Head and Neck Cancer Group'}}}}