Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-31 @ 2:38 AM
Study NCT ID:
NCT05385250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2022-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A phase II prospective observational clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of PIFs', 'timeFrame': '1 year', 'description': 'Rate of pelvic insufficience fractures (PIF) on MRI'}], 'secondaryOutcomes': [{'measure': 'Rate of symptomatic PIFs', 'timeFrame': 'after 1 and 3 year', 'description': 'Rate of symptomatic Pelvic insufficiency fractures (PIF)'}, {'measure': 'Rate of toxicity from standard organs at risk (OAR)', 'timeFrame': 'after 1 and 3 years', 'description': 'Rate of physician rated toxicity from standard OAR; bowel, bladder, skin'}, {'measure': 'Predictive and prognostic biomarkers', 'timeFrame': 'Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years', 'description': 'Prognostic value of levels of circulating DNA (copies per ML) in blood samples'}, {'measure': 'Patient reported outcomes measures (LARS)', 'timeFrame': 'Pretreatment and at 1 and 3 years', 'description': 'Patient reported outcome measure by LARS (low anterior resection syndrome) scores 1-5'}, {'measure': 'Patient reported outcome measures (FACT-BP)', 'timeFrame': 'Pretreatment and after 1 and 3 years', 'description': 'Patient reported outcome measures by Functional Assessment of Cancer Therapy - Bone Pain score'}, {'measure': 'Quality of Life measures (EORTC)', 'timeFrame': 'Pretreatment and after 1 and 3 years', 'description': 'Quality of Life measures (EORTC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anal Cancer', 'Radiotherapy Side Effect']}, 'descriptionModule': {'briefSummary': 'This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients. the trial aim to lower the risk of bone damage, while adhering with the constrains to the bowel, bladder and other conventional Organs At Risk, and finally to describe the fraction of pelvic insufficiency fractures in patients treated with optimized radiotherapy.', 'detailedDescription': 'Patients will receive standard (chemo)-radiotherapy according to national Danish Anal Cancer Group (DACG) guidelines, but the bone-sparing focus will be added to the algorithm for dose-constrains and planning objectives. A bone specific magnetic resonance scan will be performed at 1 year post treatment. Additional substudies include collection of blood samples for translational research purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with biopsy verified localized squamous cell anal cancer\n* Indication for standard (chemo)-radiotherapy with curative intend for anal cancer as per multidisciplinary team decision\n* Clinical eligible for standard (chemo)-radiotherapy as per physicians' decision\n* Written and oral consent\n* Age at least 18 years\n\nExclusion Criteria:\n\n* Previous pelvic radiotherapy\n* Previous systemic therapy with severe bone marrow suppression or hematological diseases\n* Hip-replacements\n* Contraindications to MRI-scan"}, 'identificationModule': {'nctId': 'NCT05385250', 'acronym': 'DACG-II', 'briefTitle': 'Bone-sparing Chemoradiotherapy for Anal Cancer - DACG-II', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial Danish Anal Cancer Group Study', 'orgStudyIdInfo': {'id': 'DACG-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bone sparring radiotherapy', 'description': 'Observational arm of bone-sparing radiotherapy', 'interventionNames': ['Other: Bone sparring radiotherapy']}], 'interventions': [{'name': 'Bone sparring radiotherapy', 'type': 'OTHER', 'description': 'Observation of late side effects from the pelvic bones after bone-sparring radiotherapy for anal cancer', 'armGroupLabels': ['Bone sparring radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Karen-Lise G Spindler, DMSc, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Experimental Clinical Oncology, AUH, And Danish Anal Cancer Group, DACG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karen-Lise Garm Spindler', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Vejle Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karen-Lise Garm Spindler', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}