Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
259 participants
INTERVENTIONAL
2014-05-08
2020-05-27
Brief Summary
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Detailed Description
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Registered patients will be randomised to receive either Hyperthermia and Mitomycin or Mitomycin alone. Following treatment, patients will be followed up by surveillance cystoscopy for 24 months for disease recurrence. In the first year, the follow up visits will be every 3 months from the date of start of treatment and in the second year, the visits will be every 6 months.
The study also includes translational components to determine biomarkers of response to Heated Mitomycin. Urine samples will be collected prior to surveillance cystoscopies.
This study will address the problem of how to improve the disease free survival in patients with intermediate-risk NMIBC, the treatment must have acceptable side-effects, low toxicity, and show a significant benefit over MM alone.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mitomycin
Patients will receive six consecutive weekly instillations of Mitomycin followed by surveillance
No interventions assigned to this group
Hyperthermia+Mitomycin
Patients will receive 6 weekly instillations of hyperthermia plus Mitomycin (HIVEC) using the COMBAT system, followed by surveillance cystoscopy.
Hyperthermia will be delivered in combination with each instillation using the Combat BRS system
The Combat BRS system is a temperature controlled fluid recirculation system for the delivery of hyperthermic intravesical chemotherapy. The chemotherapy fluid is circulated in a closed system and warmed by an external isolated dry system using a novel innovative laminated aluminium foil heat exchanger with a small priming volume.
Interventions
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Hyperthermia will be delivered in combination with each instillation using the Combat BRS system
The Combat BRS system is a temperature controlled fluid recirculation system for the delivery of hyperthermic intravesical chemotherapy. The chemotherapy fluid is circulated in a closed system and warmed by an external isolated dry system using a novel innovative laminated aluminium foil heat exchanger with a small priming volume.
Eligibility Criteria
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Inclusion Criteria
* Grade 2 or grade 1 stage Ta or T1 disease\*.
* Any grade G2 or G1 other than Low risk
2. Age ≥ 18 yrs
3. WHO performance status 0, 1, 2, 3
4. Pre-treatment haematology and biochemistry values within acceptable limits:
* Haemoglobin \> or =10 g/dL
* Neutrophil count \> or =1.5 x 109/L
* Platelets \> or = 100 x 109/L
* WBC \> or = 3.0 x 109/L or ANC \> or = 1.5 x 109/L
* Serum creatinine \< 1.5 x UNL
5. Negative pregnancy test for women of child-bearing potential.
6. Available for long-term follow-up.
7. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
8. Written informed consent.
Exclusion Criteria
2. Carcinoma in situ.
3. New solitary Ta G1 (small)
4. New solitary Ta G2 (small)
5. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
6. Bladder capacity \<200cc.
7. UCC involving the prostatic urethra or upper urinary tract.
8. \> or =T2 UCC
9. Known allergy to mitomycin
10. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
11. Other malignancy within the past five years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer with more than 5yrs life expectancy or any non lifethreatening tumours that have been curatively treated.
12. Concurrent chemotherapy.
18 Years
ALL
No
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Dr John Kelly
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Locations
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Royal United Hospitals Bath NHS Foundation Trust
Bath, , United Kingdom
Western General Hospital, Edinburgh
Edinburgh, , United Kingdom
Royal Surrey County Hospital NHS Foudation Trust
Guildford, , United Kingdom
The Clatterbridge Cancer Centre
Liverpool, , United Kingdom
Barnet Hospital
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
University College London Hospital, London.
London, , United Kingdom
University Hospital of South Manchester
Manchester, , United Kingdom
South Tees NHS Trust - James Cook University Hospital
Middlesbrough, , United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital
Portsmouth, , United Kingdom
East Surrey Hospital
Redhill, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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BL-2013-04
Identifier Type: -
Identifier Source: org_study_id
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