The purpose of the HIVEC II trial is to find out if the combination of the new technology called hyperthermia (the use of heat) and a drug called mitomycin is more effective than mitomycin alone which is the standard treatment for bladder cancer in reducing the chances of bladder cancer returning.
The concept of hyperthermia plus MM has been demonstrated and a phase II randomized controlled trial of ablative HM versus MM using an alternative device (Synergo) has reported tumor ablation complete response (CR) rates in 66 % of tumors treated with hyperthermia plus mitomycin compared to 22% CR for MM mono-therapy. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
259
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.
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
Western General Hospital, Edinburgh
Edinburgh, United Kingdom
Royal Surrey County Hospital NHS Foudation Trust
To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of MM alone.
The interval in whole days between the date of randomisation into the trial and the earliest of date of detection of recurrent disease, or date (known as Disease- free survival) will be measured. of death from any cause.
Time frame: After the last patient has completed 24 months follow-up
To determine if HIVEC reduces the risk of recurrence at 3 months compared to the control arm, for patients with intermediate risk disease.
The recurrence of tumor at 3 months will be calculated as a time to event outcome. recurrence of tumor at 3 months can predict subsequent recurrence and as a surrogate outcome will be monitored as a secondary measure.
Time frame: At the end of study - After all patients have been followed-up for at least 2 years
Progression Free Survival
Progression-free survival: Defined as the interval in whole days between the date of randomisation into the trial and the earliest of date of detection of disease progression, or date of death from any cause
Time frame: At the end of study - After all patients have been followed-up for at least 2 years
Recurrence-free survival.
Recurrence free survival will be measured in patients with papillary disease only. It is defined in the same way as disease free survival, with the important distinction that CIS at the first three-month post-treatment will not be included as an event, but rather considered a treatment failure and will be censored.
Time frame: At the end of study - After all patients have been followed-up for at least 2 years
To determine if Heated Mytomycin reduces the risk of progression to invasive disease compared to the control arm.
Progression Free Survival will be compared between the 2 arms. Progression free survival is defined as the interval in whole days between the date of randomisation into the trial and the earliest of date of detection of disease progression, or date of death from any cause.
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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
...and 4 more locations
Time frame: After all patients have been followed-up for at least 2 years
To compare overall and disease-specific survival between the Heated Mytomycin and the control arm.
Overall and Disease specific survival will be measured in terms of time interval. Overall survival: Defined as the interval in whole days between the date of randomisation into the trial and date of death from any cause; patients who do not die during the course of the trial will be censored at the last follow-up date. Disease specific survival: Defined as the interval in whole days between the date of randomisation into the trial and date of death due to bladder cancer. Patients who do not die during the course of the trial will be censored at the last follow-up date. Patients who die of other causes will be censored at date of death due to other cause.
Time frame: At the end of study - After all patients have been followed-up for at least 2 years
To define the safety and tolerability of Heated Mytomycin in this patient population.
Safety and Tolerability will be reported through the number of adverse events. This will include assessment of frequency, severity and nature of adverse events and the treatment received
Time frame: At the end of study - After all patients have been followed-up for at least 2 years
To compare QOL between the Heated Mytomycin and the control arms.
Quality of life will be assessed at study entry and every three months using the questionnaires. The questionnaires collects information about side effects and symptoms as well as measures of function and overall well being. For each part, a set scale will be used.
Time frame: After all patients have been followed-up for at least 2 years