Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 12:49 AM
Study NCT ID:
NCT02070120
Status:
UNKNOWN
Last Update Posted:
2020-03-19
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate with chemoresection', 'timeFrame': '3 months', 'description': "Defined as an absence of any tumour following chemoresection and will be assessed visually at 3 month check cystoscopy by patients' urologists. A biopsy of the tumour bed would take place to confirm visual assessment of complete response."}], 'secondaryOutcomes': [{'measure': 'Treatment compliance in chemoresection group', 'timeFrame': 'Duration of treatment (3 weeks)', 'description': 'Patients who receive 4 MMC instillations with no more than 14 days between each instillation will be described as fully compliant.'}, {'measure': 'Salvage surgery rates', 'timeFrame': '3 years', 'description': 'Assessing trans-urethral resection and biopsy rates following initial treatment in both treatment groups'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'Defined as time from randomisation to the first of muscle invasive bladder recurrence, recurrence in the pelvic nodes, distant metastatic recurrence or death from any cause.'}, {'measure': 'Toxicity (NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4 and Clavien Dindo grade (in surgical group))', 'timeFrame': 'up to 12 months', 'description': 'Measuring side effects of both treatments using clinician reported toxicity scales'}, {'measure': 'European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Superficial Bladder Cancer (BLS24) questionnaire', 'timeFrame': 'up to 12 months', 'description': 'Assessing side effects and impact of both treatments on patient reported quality of life.'}, {'measure': 'Health service utilisation', 'timeFrame': 'up to 12 months', 'description': 'Assessed using prospective data collection of health resource usage.'}, {'measure': 'Recurrence free interval', 'timeFrame': 'up to 12 months', 'description': 'Time from end of treatment to first relapse, in patients confirmed recurrence free at 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nonmuscle invasive bladder cancer (NMIBC)', 'Mitomycin C', 'Chemoresection'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '32124514', 'type': 'RESULT', 'citation': 'Mostafid AH, Porta N, Cresswell J, Griffiths TRL, Kelly JD, Penegar SR, Davenport K, McGrath JS, Campain N, Cooke P, Masood S, Knowles MA, Feber A, Knight A, Catto JWF, Lewis R, Hall E. CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer. BJU Int. 2020 Jun;125(6):817-826. doi: 10.1111/bju.15038. Epub 2020 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic. This multicentre study aims to establish the short term efficacy of chemoresection using chemotherapy within the bladder for the treatment of NMIBC.\n\nShould the levels of complete response following chemoresection meet predefined criteria, a larger phase III trial would be developed to assess longer term disease related endpoints, with the aim of standardising management of recurrent low risk NMIBC and potentially removing the need for over a thousand patients each year to undergo surgery.', 'detailedDescription': 'CALIBER is a two stage phase II, multicentre, randomised controlled trial (RCT). A control group has been included to provide prospective data about surgical management and outcomes and assess feasibility of recruitment to a randomised study.\n\nStage 1: 80 patients will be recruited with treatment allocated 2:1 by randomisation between chemoresection and surgical management.\n\nStage 2: If the stop/go activity criteria at the end of stage 1 indicate that recruitment should continue, 9 additional participants will be recruited, all of whom will receive chemoresection.\n\nPatients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg Mitomycin C (MMC) as outpatients. This treatment will be delivered via catheter under local anaesthetic.\n\nPatients assigned to the surgical management group will receive the standard surgical management in use at their hospital for treatment of recurrence which may include a single post-operative installation of 40mg MMC within 24 hours.\n\nAll participants will be followed up at 3 weeks from the start of treatment (ie at time of final MMC instillation for chemoresection group) and each will receive a cystoscopy three months from the end of treatment to assess response, in accordance with European Association of Urology (EAU) guidelines.\n\nSubsequent cystoscopic follow up will take place 12 months after treatment if recurrence-free at 3 months and then annually.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of ≤6 using EORTC risk tables\n* Histologically confirmed Transitional-cell carcinoma (TCC) at original diagnosis\n* Aged 16 or over\n* Satisfactory pre-treatment haematology values and serum creatinine \\< 1.5 x Upper Limit of Normal (ULN)\n* Negative pregnancy test for women of child-bearing potential\n\nExclusion Criteria:\n\n* Any history of: grade 3/high grade or ≥T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter\n* Any history of histologically confirmed non-TCC bladder cancer\n* Trial entry recurrence identified within 11.5 months of the date of the original diagnosis\n* Any prior treatment of the trial entry recurrence (including biopsy)\n* Previous MMC chemotherapy other than a single instillation at diagnostic surgery\n* Known allergy to MMC\n* Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)\n* Known or suspected reduced bladder capacity (\\<100ml)\n* Significant bleeding disorder\n* Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.\n* Active or intractable urinary tract infection\n* Urethral stricture or anything impeding the insertion of a catheter\n* Large narrow neck diverticula\n* Significant urinary incontinence\n* Any other conditions that in the Principal Investigator's opinion would contraindicate protocol treatment\n* Unable or unwilling to comply with study procedures or follow up schedule"}, 'identificationModule': {'nctId': 'NCT02070120', 'acronym': 'CALIBER', 'briefTitle': 'Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Cancer Research, United Kingdom'}, 'officialTitle': 'CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'ICR-CTSU/2013/10041'}, 'secondaryIdInfos': [{'id': '2013-005095-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemoresection', 'description': '4 once weekly outpatient intravesical instillations 40mg Mitomycin C', 'interventionNames': ['Drug: Mitomycin C']}, {'type': 'OTHER', 'label': 'Surgical Management', 'description': 'Surgical management according to local practice', 'interventionNames': ['Procedure: Surgical Management']}], 'interventions': [{'name': 'Mitomycin C', 'type': 'DRUG', 'otherNames': ['MMC'], 'description': 'Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.', 'armGroupLabels': ['Chemoresection']}, {'name': 'Surgical Management', 'type': 'PROCEDURE', 'description': 'Patients in this group should be treated according to local practice. Surgical interventions may include transurethral resection (TUR) or ablation.', 'armGroupLabels': ['Surgical Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SK10 3BL', 'city': 'Macclesfield', 'state': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Macclesfield District General Hospital', 'geoPoint': {'lat': 53.26023, 'lon': -2.12564}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'state': 'Cleveland', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'CA28 8JG', 'city': 'Whitehaven', 'state': 'Cumbria', 'country': 'United Kingdom', 'facility': 'West Cumberland Hospital', 'geoPoint': {'lat': 54.54897, 'lon': -3.58412}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'DT1 2JY', 'city': 'Dorchester', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'zip': 'CA2 7HY', 'city': 'Carlisle', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cumberland Infirmary', 'geoPoint': {'lat': 54.8951, 'lon': -2.9382}}, {'zip': 'CM1 5ET', 'city': 'Chelmsford', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Broomfield Hospital', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'CM20 1QX', 'city': 'Harlow', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'zip': 'GL53 7AN', 'city': 'Cheltenham', 'state': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Cheltenham General Hospital', 'geoPoint': {'lat': 51.90006, 'lon': -2.07972}}, {'zip': 'GL1 3NN', 'city': 'Gloucester', 'state': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'OL1 2JH', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Royal Oldham Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'RG24 9NA', 'city': 'Basingstoke', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Basingstoke and North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'HR1 2ER', 'city': 'Hereford', 'state': 'Herefordshire', 'country': 'United Kingdom', 'facility': 'Hereford County Hospital', 'geoPoint': {'lat': 52.05684, 'lon': -2.71482}}, {'zip': 'DA2 8DA', 'city': 'Dartford', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Darent Valley Hospital', 'geoPoint': {'lat': 51.44657, 'lon': 0.21423}}, {'zip': 'ME7 5NY', 'city': 'Gillingham', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Medway Maritime Hospital', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'OX3 7LE', 'city': 'Headington', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}, {'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'state': 'Suffolk', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'CR7 7YE', 'city': 'Croydon', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Croydon University Hospital', 'geoPoint': {'lat': 51.38333, 'lon': -0.1}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'New Cross Hospital', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}, {'zip': 'PO19 6SE', 'city': 'Chichester', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': "St Richard's Hospital", 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'BN11 2DH', 'city': 'Worthing', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': 'Worthing Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Pinderfields General Hospital', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}, {'zip': 'DY11 6RJ', 'city': 'Kidderminster', 'state': 'Worcestershire', 'country': 'United Kingdom', 'facility': 'Kidderminster Hospital', 'geoPoint': {'lat': 52.38819, 'lon': -2.25}}, {'zip': 'B98 7UB', 'city': 'Redditch', 'state': 'Worcestershire', 'country': 'United Kingdom', 'facility': 'Alexandra Hospital', 'geoPoint': {'lat': 52.3065, 'lon': -1.94569}}, {'zip': 'WR5 1DD', 'city': 'Worcester', 'state': 'Worcestershire', 'country': 'United Kingdom', 'facility': 'Worcester Royal Hospital', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 2LR', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Withington Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Hugh Mostafid', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Surrey County Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}