Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-01-02 @ 4:36 AM
Study NCT ID:
NCT05055635
Status:
RECRUITING
Last Update Posted:
2021-09-24
First Post:
2021-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2030-07-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local control', 'timeFrame': '12 months', 'description': 'MRI'}], 'secondaryOutcomes': [{'measure': 'Local re-recurrence', 'timeFrame': '6 and 24 months'}, {'measure': 'Progression free survival', 'timeFrame': '3-5 year FU'}, {'measure': 'Overall survival', 'timeFrame': '3-5 year FU'}, {'measure': 'Pathological evaluation of R0, R1 or R2 resection', 'timeFrame': '6 months'}, {'measure': 'Toxicity', 'timeFrame': 'up to 6 weeks, 1 year, 3 year', 'description': 'evaluated by NCI-CTCAE v. 5.0'}, {'measure': 'Quality of life assessment', 'timeFrame': 'up to 6 weeks, 1 year, 3 year', 'description': 'EORTC QLQ-c30'}, {'measure': 'Quality of life assessment', 'timeFrame': 'up to 6 weeks, 1 year, 3 year', 'description': 'QLQ-CR29'}, {'measure': 'Quality of life assessment', 'timeFrame': 'up to 6 weeks, 1 year, 3 year', 'description': 'QLQ-ANL27'}, {'measure': 'Quality of life assessment', 'timeFrame': 'up to 6 weeks, 1 year, 3 year', 'description': 'LARS score'}, {'measure': 'Translational research', 'timeFrame': 'baseline, end of therapy, 1 year', 'description': 'cfDNA'}, {'measure': 'Summed radiotherapy dose volume to organs at risk and correlation to toxicities', 'timeFrame': 'up to 6 weeks, 1 year, 3 year'}, {'measure': 'To investigate 30-day surgical overall morbidity', 'timeFrame': '30-day', 'description': 'Clavien-Dindo'}, {'measure': 'To investigate 6-month surgical site morbidity', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anal Cancer', 'Recurrent Anal Cancer']}, 'descriptionModule': {'briefSummary': 'This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent anal cancer\n* Bioptically verified (squamous cell carcinoma)\n* Available dose plan from primary radiotherapy\n* Previous RT (\\>30Gy EQD2)\n* Evaluated in MDT-conferences (Herlev, Aarhus)\n* Age\\>18 years\n* PS 0-2\n* Adequate organ function\n* Written informed consent\n\nExclusion Criteria:\n\n* Distant metastases deemed without curative intended treatment options (PET-CT)\n* Unable to undergo MRI, PET-CT\n* Inability to attend full course radiotherapy and follow up in the outpatient clinic.'}, 'identificationModule': {'nctId': 'NCT05055635', 'acronym': 'ReRad III', 'briefTitle': 'Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy', 'orgStudyIdInfo': {'id': 'DCPT070721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doseescalated pencil beam proton therapy', 'description': 'Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day.', 'interventionNames': ['Radiation: Pencil beam proton therapy']}], 'interventions': [{'name': 'Pencil beam proton therapy', 'type': 'RADIATION', 'description': 'Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day', 'armGroupLabels': ['Doseescalated pencil beam proton therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'state': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Camilla Kronborg, MD, PhD', 'role': 'CONTACT', 'email': 'camkro@rm.dk', 'phone': '+45 7845 0000'}], 'facility': 'Danish Centre for Particle Therapy', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Camilla Kronborg, MD, PhD', 'role': 'CONTACT', 'email': 'camkro@rm.dk', 'phone': '+45 78 45 00 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}