Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-07 @ 12:26 PM
Study NCT ID:
NCT02384733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-07-08
First Post:
2015-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2963}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2032-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of ipsilateral arm lymphedema', 'timeFrame': '3 years', 'description': '\\>=10% increased arm circumference compared to the other arm defines edema'}], 'secondaryOutcomes': [{'measure': 'Fibrosis grade 2-3', 'timeFrame': '3 years', 'description': 'Breast or chest wall induration'}, {'measure': 'Arm range of motion', 'timeFrame': '3 years', 'description': 'Impaired shoulder movement is present when \\>20 degrees difference between arms at flexion and/or abduction'}, {'measure': 'Development of dyspigmentation', 'timeFrame': '3 years', 'description': 'Grade 2 or worse dyspigmentation compared to baseline'}, {'measure': 'Recurrence', 'timeFrame': '10 years', 'description': 'Any recurrence location and time to event'}, {'measure': 'Development of pain in the irradiated area', 'timeFrame': '3 years', 'description': 'Pain in the irradiated area measured on visual analog scale compared to baseline'}, {'measure': 'Change in sensibility', 'timeFrame': '3 years', 'description': 'Change in sensibility in the irradiated area compared to baseline measured as yes/no'}, {'measure': 'Development of edema on breast / chest wall', 'timeFrame': '3 years', 'description': 'Grade 2 or worse edema'}, {'measure': 'Development of telangiectasia in irradiated area', 'timeFrame': '3 years', 'description': 'Grade 2 or worse telangiectasia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Radiation induced morbidity, recurrence'], 'conditions': ['Lymphedema', 'Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.', 'detailedDescription': 'The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:\n\n63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.\n\nThe primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.\n\nThe hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOperated for early node-positive breast cancer with indication for loco-regional breast radiotherapy\n\nExclusion Criteria:\n\nPrevious radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up'}, 'identificationModule': {'nctId': 'NCT02384733', 'briefTitle': 'Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost', 'organization': {'class': 'OTHER', 'fullName': 'Danish Breast Cancer Cooperative Group'}, 'officialTitle': 'The Skagen Trial 1, Moderately Hypofractionated Loco-regional Adjuvant Radiation Therapy of Early Breast Cancer Combined With a Simultaneous Integrated Boost: a Randomised Clinically Controlled Trial', 'orgStudyIdInfo': {'id': 'The Skagen Trial 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated loco-regional RT', 'description': '40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions weekly', 'interventionNames': ['Radiation: Loco-regional RT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normofractionated loco-regional RT', 'description': '50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly', 'interventionNames': ['Radiation: Loco-regional RT']}], 'interventions': [{'name': 'Loco-regional RT', 'type': 'RADIATION', 'armGroupLabels': ['Hypofractionated loco-regional RT', 'Normofractionated loco-regional RT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Lars Stenbygaard, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Troels Bechmann, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vejle Hospital'}, {'name': 'Mette Nielsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}, {'name': 'Birgitte Offersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Hanne Nielsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Claus Kamby, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Sami Al-Rawi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Naestved Hospital'}, {'name': 'Mechthild Krause, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Technische Universität Dresden Klinik und Poliklinik für Strahlentherapie und Radioonkologie'}, {'name': 'Andreas Schreiber, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Praxis für Strahlentherapie, Dresden'}, {'name': 'Ingvil Mjaaland, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stavanger Hospital'}, {'name': 'Tanja Marinko, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Oncology Ljubljana'}, {'name': 'Carine Kirkove, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radiotherapy Department Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels'}, {'name': 'Egil Blix, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of North Norway, Tromsoe'}, {'name': 'Unn-Miriam Kasti', 'role': 'STUDY_CHAIR', 'affiliation': 'Kristiansand Hospital, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Breast Cancer Cooperative Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, professor, ph.d.', 'investigatorFullName': 'Birgitte Offersen', 'investigatorAffiliation': 'Danish Breast Cancer Cooperative Group'}}}}