NCT01094964Unknown3 期
HYMN: A Randomized Controlled Phase III Trial Comparing Hyperthermia Plus Mitomycin to a Second Course of Bacillus Calmette-Guerin or Standard Therapy in Patients With Recurrence of Non-Muscle Invasive Bladder Cancer Following Induction or Maintenance Bacillus Calmette-Guerin Therapy
Cancer Research Campaign Clinical Trials Centre18 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2009年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 242
- 试验地点
- 18
- 主要终点
- Disease-free survival time
研究概览
简要总结
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Drugs used in chemotherapy, such as mitomycin C and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as bacillus calmette-guerin (BCG) and interferon alfa, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether giving hyperthermia together with mitomycin C is more effective than giving BCG or standard therapy as second-line therapy in treating patients with recurrent bladder cancer.
PURPOSE: This randomized phase III trial is studying how well hyperthermia given together with mitomycin C works compared with BCG or standard therapy as second-line therapy in treating patients with recurrent bladder cancer.
详细描述
OBJECTIVES:
Primary
- To determine whether hyperthermia in combination with mitomycin C versus bacillus Calmette-Guerin (BCG) or standard therapy as second-line therapy is effective in patients with recurrent non-muscle invasive bladder cancer following induction or maintenance therapy with BCG.
- To compare disease-free survival time in all patients.
- To compare complete response rate at 3 months in patients with carcinoma in situ.
Secondary
- To compare progression-free survival, overall survival, safety and tolerability of treatments, quality of life, cost, and cost-effectiveness in these patients.
- To assess biomarkers of response to standard and investigational treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of non-muscle invasive bladder cancer
- •Recurrent disease after undergoing induction or maintenance therapy with bacillus Calmette-Guérin (BCG), meeting any 1 of the following criteria:
- •Stage Ta or T1 disease (grade 2 or 3)
- •Carcinoma in situ with stage Ta or T1 disease (grade 1, 2, or 3)
- •Carcinoma in situ alone
- •Has undergone a second resection of all T1 disease to exclude muscle invasive disease
- •No urothelial cell carcinoma (UCC) ≥ T2
- •No recurrence of grade 1 UCC following BCG induction therapy
- •No UCC involving the prostatic urethra or upper urinary tract
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-4
- •WBC ≥ 3.0 x 10^9/L
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Hemoglobin ≥ 10 g/dL
- •Platelet count ≥ 100 x 10^9/L
- •Serum creatinine < 1.5 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Normal kidneys and ureters on imaging CT scan within the past 12 months
- •Available for long-term follow-up with a life expectancy of the duration of the trial
- •Must be fit and willing to undergo a full or partial cystectomy
- •No known or suspected reduced bladder capacity (< 250 mL)
- •No significant bleeding disorder
- •No other malignancy within the past 5 years except nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, or DCIS/LCIS of the breast
- •No known allergy to mitomycin or bacillus Calmette-Guérin (BCG), or previously withdrawn from BCG treatment due to a related adverse event (e.g., systemic infection)
- •No active or intractable urinary tract infection
- •No urethral stricture or any situation impeding the insertion of a 20F catheter
- •No bladder diverticula > 1 cm
- •No significant urinary incontinence
- •No concurrent implanted electronic devices (e.g., cardiac pacemakers) or metallic implants within the pelvis, lower torso, spine, hip, or upper femur
- •No immunocompromised state for any reason
- •PRIOR CONCURRENT THERAPY:
- •At least 6 months since prior intravesical chemotherapy, except for single instillation post-transurethral resection
- •No prior pelvic irradiation
- •No prior hyperthermia in combination with intravesical mitomycin
- •Concurrent participation in other studies allowed
- •No current or long-term use of corticosteroids
- •No concurrent chemotherapy
排除标准
- 未提供
结局指标
主要结局
Disease-free survival time
Complete response rate at 3 months in patients with carcinoma in situ
次要结局
- Overall survival time
- Disease-specific survival time
- Progression-free survival time
- Recurrence-free survival time
- Safety and tolerability
- Quality of Life
- Cost effectiveness
- Biomarkers of response to standard and investigational treatment
研究者
研究点 (18)
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