A Phase II, Open Label, Multicentre, Randomised Controlled Trial Comparing Hyperthermia Plus Mitomycin To Mitomycin Alone In Patients With Intermediate Risk Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 14
- 主要终点
- To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of MM alone.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New or Recurrence of intermediate risk NMIBC following TURBT defined as;
- •Grade 2 or grade 1 stage Ta or T1 disease*.
- •Any grade G2 or G1 other than Low risk
- •Age ≥ 18 yrs
- •WHO performance status 0, 1, 2, 3
- •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
- •Negative pregnancy test for women of child-bearing potential.
- •Available for long-term follow-up.
- •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.
- •Written informed consent.
排除标准
- •Grade 3 TCC
- •Carcinoma in situ.
- •New solitary Ta G1 (small)
- •New solitary Ta G2 (small)
- •Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
- •Bladder capacity <200cc.
- •UCC involving the prostatic urethra or upper urinary tract.
- •> or =T2 UCC
- •Known allergy to mitomycin
- •Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
- •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.
- •Concurrent chemotherapy.
研究组 & 干预措施
Mitomycin
Patients will receive six consecutive weekly instillations of Mitomycin followed by surveillance
Hyperthermia+Mitomycin
Patients will receive 6 weekly instillations of hyperthermia plus Mitomycin (HIVEC) using the COMBAT system, followed by surveillance cystoscopy.
干预措施: Hyperthermia will be delivered in combination with each instillation using the Combat BRS system (Device)
结局指标
主要结局
To determine if HIVEC increases disease-free survival at 24 months compared to the comparator arm of MM alone.
时间窗: After the last patient has completed 24 months follow-up
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.
次要结局
- To determine if HIVEC reduces the risk of recurrence at 3 months compared to the control arm, for patients with intermediate risk disease.(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.(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.(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.(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.(After all patients have been followed-up for at least 2 years)
- Progression Free Survival(At the end of study - After all patients have been followed-up for at least 2 years)
- Recurrence-free survival.(At the end of study - After all patients have been followed-up for at least 2 years)