Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT01341535
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2011-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-21', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment.', 'timeFrame': 'at 1 year', 'description': '18F-FDG-PET/CT scans will be performed.'}], 'secondaryOutcomes': [{'measure': 'Regional (elective neck) and distant control.', 'timeFrame': 'after 1 year', 'description': '18F-FDG-PET/CT scans will be performed.'}, {'measure': 'Topography of local and/or regional relapse.', 'timeFrame': 'during the first year post-treatment', 'description': '18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse'}, {'measure': 'Tumor response', 'timeFrame': '3 months post-treatment', 'description': '18F-FDG-PET/CT scans will be performed'}, {'measure': 'Acute toxicity', 'timeFrame': 'up to 12 months of follow-up'}, {'measure': 'Overall disease-specific, disease-free survival.', 'timeFrame': 'at 1 year'}, {'measure': 'Late toxicity', 'timeFrame': 'up to 12 months of follow-up'}, {'measure': 'Time point of local and/or regional relapse.', 'timeFrame': 'during the first year post-treatment', 'description': '18F-FDG-PET/CT scans will be performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Non-operated Squamous Cell Carcinoma of Oral Cavity', 'Primary Non-operated Squamous Cell Carcinoma of Oropharynx', 'Primary Non-operated Squamous Cell Carcinoma of Hypopharynx', 'Primary Non-operated Squamous Cell Carcinoma of Larynx']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx\n* Primary unresectable tumor and/or patients that refused surgery\n* Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer\n* Multidisciplinary decision of curative radiotherapy or radiochemotherapy\n* Karnofsky performance status \\>= 70 %\n* Age \\>= 18 years old\n* Informed consent obtained, signed and dated before specific protocol procedures\n\nExclusion Criteria:\n\n* High risk Human Papilloma Virus (HPV)\n* Treatment combined with brachytherapy\n* Prior irradiation to the head and neck region\n* History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.\n* Distant metastases\n* Pregnant or lactating women\n* Creatinine clearance (Cockcroft-Gault) =\\< 60 mL/min\n* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study\n* Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.'}, 'identificationModule': {'nctId': 'NCT01341535', 'acronym': 'C-ART-2', 'briefTitle': 'Comparison of Adaptive Dose Painting by Numbers With Standard Radiotherapy for Head and Neck Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'A Two-arm Phase II Randomized Study, Comparing Adaptive Biological Imaging - Voxel Intensity - Based Radiotherapy (Adaptive Dose Escalation) Versus Standard Radiotherapy for Head and Neck Cancer.', 'orgStudyIdInfo': {'id': '2010/567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adaptive DPBN', 'description': 'This patient group will be treated by adaptive dose-painting-by-numbers, while patients in the control arm will receive standard treatment.\n\nPatients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.', 'interventionNames': ['Radiation: Adaptive dose-painting-by-numbers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard IMRT', 'description': 'This patient group will be treated by standard intensity-modulated radiotherapy (IMRT), while patients in the experimental arm will receive adaptive dose-painting-by-numbers.\n\nPatients will have a 50 % chance of being allocated to the experimental arm and a 50 % chance of being allocated to the control arm.', 'interventionNames': ['Radiation: standard intensity-modulated radiotherapy (IMRT)']}], 'interventions': [{'name': 'Adaptive dose-painting-by-numbers', 'type': 'RADIATION', 'description': 'Adaptive dose escalation by dose-painting-by-numbers.', 'armGroupLabels': ['adaptive DPBN']}, {'name': 'standard intensity-modulated radiotherapy (IMRT)', 'type': 'RADIATION', 'description': 'Standard radiotherapy for head and neck cancer.', 'armGroupLabels': ['standard IMRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Department of Radiotherapy, University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Namur', 'country': 'Belgium', 'facility': 'Clinique & Materinité Sainte Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}], 'overallOfficials': [{'name': 'Wilfried De Neve, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}