Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT01810757
Status:
UNKNOWN
Last Update Posted:
2016-08-10
First Post:
2013-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Weekly Radiotherapy for Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-04', 'releaseDate': '2024-06-26'}, {'resetDate': '2025-01-15', 'releaseDate': '2024-11-27'}, {'releaseDate': '2025-12-23'}], 'estimatedResultsFirstSubmitDate': '2024-06-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-09', 'studyFirstSubmitDate': '2013-03-08', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.', 'timeFrame': '12 weeks from start of radiotherapy', 'description': 'Acute CTC non-genitourinary toxicity grade 3 or higher.'}], 'secondaryOutcomes': [{'measure': 'Local control', 'timeFrame': '3 months', 'description': 'Presence of cancer in the bladder 3 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '32461298', 'type': 'DERIVED', 'citation': 'Hafeez S, Patel E, Webster A, Warren-Oseni K, Hansen V, McNair H, Miles E, Lewis R, Hall E, Huddart R. Protocol for hypofractionated adaptive radiotherapy to the bladder within a multicentre phase II randomised trial: radiotherapy planning and delivery guidance. BMJ Open. 2020 May 26;10(5):e037134. doi: 10.1136/bmjopen-2020-037134.'}]}, 'descriptionModule': {'briefSummary': "Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option.\n\nRadiotherapy treatment is planned based on information from a CT scan which shows the position and shape of the bladder. This plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. A safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.\n\nIt is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. In this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects.\n\nAims\n\nIn patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:\n\n1. whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity\n2. the local tumour control rate achieved by hypofractionated weekly radiotherapy\n3. the requirement to treat with adaptive planning.\n\nHow results will be used Results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. The randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age ≥18 years\n* Histologically confirmed invasive bladder carcinoma (T2-T4a N0 M0; any histological sub-type)\n* Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, co-morbidity, patient refusal)\n* Expected survival \\>6 months\n* WHO performance status 0-3\n* Willing to undergo post treatment cystoscopy\n\nExclusion Criteria:\n\n* Nodal or metastatic disease\n* Concurrent malignancy\n* Previous pelvic radiotherapy\n* Urinary catheter in-situ\n* Any other contra-indication to radiotherapy (e.g. inflammatory bowel disease)\n* Unable to attend for post treatment follow up'}, 'identificationModule': {'nctId': 'NCT01810757', 'acronym': 'HYBRID', 'briefTitle': 'Study of Weekly Radiotherapy for Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning', 'orgStudyIdInfo': {'id': 'CCR3973'}, 'secondaryIdInfos': [{'id': 'CRUK/12/055', 'type': 'OTHER_GRANT', 'domain': 'CRUK'}, {'id': 'ICR-CTSU/2013/10039', 'type': 'OTHER', 'domain': 'ICR-CTSU Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard planning', 'description': 'Standard planning radiotherapy', 'interventionNames': ['Radiation: Standard planning radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Adaptive planning', 'description': 'Adaptive planning radiotherapy', 'interventionNames': ['Radiation: Adaptive planning radiotherapy']}], 'interventions': [{'name': 'Standard planning radiotherapy', 'type': 'RADIATION', 'description': '36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.', 'armGroupLabels': ['Standard planning']}, {'name': 'Adaptive planning radiotherapy', 'type': 'RADIATION', 'description': '36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.', 'armGroupLabels': ['Adaptive planning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Centre', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's & St Thomas's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHSFT', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'facility': 'Clatterbridge Cancer Centre', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk & Norwich University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Preston', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}, {'city': 'Romford', 'country': 'United Kingdom', 'facility': 'Queens Hospital', 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}], 'overallOfficials': [{'name': 'Robert Huddart', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Cancer Research/RMNHSFT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-26', 'type': 'RELEASE'}, {'date': '2024-10-04', 'type': 'RESET'}, {'date': '2024-11-27', 'type': 'RELEASE'}, {'date': '2025-01-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Institute of Cancer Research, United Kingdom'}}}}