EUCTR2008-005428-99-GB进行中（未招募）1 期
A randomised 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. - Hyperthermia plus mitomycin (HYMN)
niversity College London0 个研究点目标入组 104 人开始时间: 2010年7月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion Criteria
- •1. Previous BCG induction or maintenance therapy for NMIBC.
- •2. Recurrence of disease following induction or maintenance BCG defined as;
- •Grade 3 or grade 2 stage Ta or T1 disease.
- •CIS with grade 3, grade 2 or grade 1 stage Ta or T1 disease
- •Carcinoma in situ (CIS) alone
- •3. Have undergone a re-resection of all T1 disease to exclude muscle invasive disease.
- •4. Age 18 yrs or older
- •5. WHO performance status 0, 1, 2, 3 or 4
- •6. Normal kidneys and ureters on imaging study within the past 12 months
- •7. Pre-treatment haematology and biochemistry values within acceptable limits:
- •- haemoglobin equal or greater than 10 g/dL
- •- platelets equal or greater than 100 x 10^9/L
- •- WBC equal or greater than 3.0 x 10^9/L or ANC equal or greater than 1.5 x 10^9/L
- •- Serum creatinine less than 1.5 x UNL
- •8. Negative pregnancy test for women of child-bearing potential.
- •9. Available for long-term follow-up.
- •10. Unfit or unwilling to have a full or partial cystectomy
- •11. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Patients with any of the following are not eligible for the trial:
- •1. Recurrence of grade 1 UCC withour CIS following BCG induction.
- •2. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
- •3. UCC involving the prostatic urethra or upper urinary tract.
- •4. T2 or higher stage UCC
- •5. Known or suspected reduced bladder capacity (less than 250 mls)
- •6. Significant bleeding disorder.
- •7. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
- •8. Current or long-term use of oral corticosteroids, or patients with an immunocompromised state for any reason.
- •9. 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 stable prostate cancer (under active surveillance or hormone control) with a life expectancy of more than >5 years.
- •10. Concurrent chemotherapy or any previous HM treatment.
- •11. Any known allergy or adverse event that would prevent them receiving a treatment that they may be randomised to within the trial.
- •12. Active or intractable UTI
- •13. Urethral stricture, or any situation impeding the insertion of a 20F catheter.
- •14. Bladder diverticular >1cm.
- •15. Significant Urinary incontinence
- •16. History of pelvic irradiation
- •17. Patients with implanted electronic devices (such as cardiac pacemakers) or metallic implants within the pelvis, lower torso, spine, hip or upper femur.
- •18. Suitable and willing to have, or have had, a full or partial cystectomy.
研究者
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