Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-01 @ 3:15 PM
Study NCT ID:
NCT05295992
Status:
RECRUITING
Last Update Posted:
2023-03-14
First Post:
2022-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Rate CTCAE GI Toxicity', 'timeFrame': 'Start of radiotherapy to 3 months after end of radiotherapy', 'description': 'Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea'}], 'secondaryOutcomes': [{'measure': 'All Early CTCAE Treatment Related Toxicities', 'timeFrame': 'From start of radiotherapy through 3 months after end of radiotherapy', 'description': 'All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity'}, {'measure': 'All Late CTCAE Treatment Related Toxicities', 'timeFrame': 'From 3 months after end of radiotherapy through 2 years follow-up', 'description': 'All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above'}, {'measure': 'Patient Reported Outcomes (PRO)', 'timeFrame': 'Baseline through 2 year follow-up', 'description': 'Collection of NCI PRO-CTCAE questionnaire'}, {'measure': 'EORTC Quality of Life Assessment', 'timeFrame': 'Baseline through 2 year follow-up', 'description': 'Collection of EORTC QLQ C30'}, {'measure': 'EuroQol Quality of Life Assessment', 'timeFrame': 'Baseline through 2 year follow-up', 'description': 'Collection EQ-5D-5L questionnaires'}, {'measure': 'Local Progression Free Survival', 'timeFrame': 'From time of inclusion to local progression, assessed up to 24 months post treatment', 'description': 'Local progression free survival'}, {'measure': 'Local Control', 'timeFrame': 'At 12 and 24 months', 'description': 'Local control (freedom from local progression)'}, {'measure': 'Progression Free Survival', 'timeFrame': 'From time of inclusion to disease progression, assessed up to 24 months post treatment', 'description': 'Progression free survival (from time of inclusion to disease progression)'}, {'measure': 'Overall Survival', 'timeFrame': 'From time of inclusion to death from any cause, assessed up to 24 months post treatment', 'description': 'Overall survival'}, {'measure': 'Disease Free Survival', 'timeFrame': 'From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment', 'description': 'Disease Free Survival'}, {'measure': 'Treatment Related Hospitalization', 'timeFrame': 'From of start of radiation therapy through 2 year follow-up', 'description': 'Hospitalization due to adaptive radiation therapy treatment related toxicity'}, {'measure': 'Workflow Feasibility', 'timeFrame': 'From start of radiation therapy through end of external beam treatment (approximately 6 weeks)', 'description': 'Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle-Invasive Bladder Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically proven bladder cancer\n2. Urothelial carcinoma\n3. Age ≥ 18 years\n4. Stage T1b-T4AN0M0\n5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion\n6. Suitable for radiotherapy\n7. ECOG/WHO performance status 0-2\n8. Written informed consent\n9. For Cohort B, participant's must have normal organ and marrow function as defined below:\n\n * leukocytes ≥2,500/mcL\n * absolute neutrophil count ≥1,500/mcL\n * platelets ≥100,000/mcL\n * hemoglobin ≥9 g/dL\n * total bilirubin ≤ 1,5 ULN\n * AST(SGOT)/ALT(SGPT) ≤3 × ULN\n * alkaline phosphatase ≤2.5 × ULN\n * creatinine clearance \\<25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance \\<50 ml/min.\n * INR and aPTT £1.5 ULN\n\nExclusion Criteria:\n\n1. Prior pelvic radiation therapy\n2. Inability to comply with the protocol\n3. Presence of a hip prothesis\n4. Grade 2 or greater baseline diarrhea\n5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)"}, 'identificationModule': {'nctId': 'NCT05295992', 'acronym': 'ARTIA-Vesica', 'briefTitle': 'Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach', 'organization': {'class': 'INDUSTRY', 'fullName': 'Varian, a Siemens Healthineers Company'}, 'officialTitle': 'Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)', 'orgStudyIdInfo': {'id': 'VAR-2021-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily Adaptive External Beam Radiation Therapy', 'description': 'Daily adaptive radiation therapy delivered with Varian Ethos treatment system.', 'interventionNames': ['Device: Varian Ethos Adaptive Radiation Therapy']}], 'interventions': [{'name': 'Varian Ethos Adaptive Radiation Therapy', 'type': 'DEVICE', 'description': 'Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.', 'armGroupLabels': ['Daily Adaptive External Beam Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Katrine Storm', 'role': 'CONTACT', 'email': 'katrine.smedegaard.storm@regionh.dk'}], 'facility': 'Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Steve Kohlmyer, MS', 'role': 'CONTACT', 'email': 'steve.kohlmyer@varian.com', 'phone': '12062760076'}, {'name': 'Sean Davidson, MS', 'role': 'CONTACT', 'email': 'sean.davidson@varian.com'}], 'overallOfficials': [{'name': 'Katrine Storm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital, Copenhagen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Varian, a Siemens Healthineers Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}