Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT02352792
Status:
UNKNOWN
Last Update Posted:
2015-02-02
First Post:
2015-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-01-30', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to local recurrence', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Local control'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy\n* measurabel disease by CT and/or MRT and/or FDG-PET-CT\n* fit for chemotherapy\n* no prior radiotherapy or major surgery in the head/neck region\n* Karnofsky Index \\> 60%\n* informed consent\n\nExclusion Criteria:\n\n* uncontrolled secondary cancer\n* distant metastases\n* pregnancy\n* expected malcompliance'}, 'identificationModule': {'nctId': 'NCT02352792', 'briefTitle': 'Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy', 'orgStudyIdInfo': {'id': '2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'description': 'Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)', 'interventionNames': ['Radiation: radiochemotherapy with 70 Gy']}, {'type': 'EXPERIMENTAL', 'label': 'dose escalation', 'description': 'Standard plus 10% dose escalation to the hypoxic volume', 'interventionNames': ['Radiation: radiochemotherapy with 77 Gy']}], 'interventions': [{'name': 'radiochemotherapy with 70 Gy', 'type': 'RADIATION', 'armGroupLabels': ['Standard therapy']}, {'name': 'radiochemotherapy with 77 Gy', 'type': 'RADIATION', 'armGroupLabels': ['dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Welz, Dr. med.', 'role': 'CONTACT', 'email': 'stefan.welz@med.uni-tuebigen.de', 'phone': '+49 7071 29 86144'}], 'facility': 'Tuebingen university, radiation oncology', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Daniel Zips, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'daniel.zips@med.uni-tuebingen.de', 'phone': '+49 7071 29 82141'}, {'name': 'Silke Theden, Mrs.', 'role': 'CONTACT', 'email': 'silke.theden@med-uni-tuebingen.de', 'phone': '+49 7071 29 83420'}], 'overallOfficials': [{'name': 'Stefan Welz, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'radiation oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}