ISRCTN85785327终止3 期
A randomised controlled phase III trial comparing hyperthermia plus mitomycin to a second course of Bacillus Calmette-Guerin (BCG) or standard therapy in patients with recurrence of non-muscle invasive bladder cancer following induction or maintenace BCG therapy
niversity College London (UK)0 个研究点目标入组 242 人开始时间: 2009年5月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 242
研究概览
简要总结
- 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30274699
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Both males and females, age >=18 years
- •2. Previous BCG induction or maintenance therapy for non-muscle-invasive bladder cancer (NMIBC)
- •3. Recurrence of disease following induction or maintenance BCG defined as:
- •3.1. Grade 3 or Grade 2, stage Ta or T1 disease
- •3.2. Carcinoma in situ (CIS) with Grade 3, Grade 2 or Grade 1 stage Ta or T1 disease
- •3.3. CIS alone
- •4. Have undergone a re-resection of all T1 disease to exclude muscle invasive disease
- •5. World Health Organization (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:
- •7.1. Haemoglobin >=10 g/dl
- •7.2. Platelets >=100 x 10^9/l
- •7.3. White blood cells (WBC) >=3.0 x 10^9/l or absolute neutrophil count (ANC) >=1.5 x 10^9/l
- •7.4. Serum creatinine <1.5 x Upper Normal Limit (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 cystectomy
- •11. Written informed consent
- •*Imaging of high risk recurrent UCC by computerised tomography (CT) scan is routinely performed in some centres and is recommended as good practice in this trial.
排除标准
- •Current exclusion criteria as of 11/02/2013:
- •1. Recurrence of Grade 1 UCC 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 UCC
- •5. Known or suspected reduced bladder capacity (<250 ml)
- •6. Significant bleeding disorder.
- •7. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active
- •8. Patients with an immuno-compromised state for any reason except patients on current or long term use of corticosteroids. As good clinical practice it is recommended to notify the consultant who prescribed the corticosteroids of the HYMN treatment the patient will receive.
- •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 ductal carcinoma in situ (DCIS)/Lobular Carcinoma in Situ (LCIS) of the breast
- •10. Concurrent chemotherapy or any previous HM
- •11. Any known allergy or adverse event that would prevent them receiving the Hyperthermia+Mitomycin treatment
- •12. Active or intractable urinary tract infection (UTI)
- •13. Urethral stricture, or any situation impending the insertion of a 20F catheter
- •14. Bladder diverticula >1 cm
- •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
- •Previous exclusion criteria until 11/02/2013:
- •1. Recurrence of Grade 1 UCC 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 UCC
- •5. Known or suspected reduced bladder capacity (<250 ml)
- •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 corticosteroids or patients with an immuno-compromised 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 ductal carcinoma in situ (DCIS)/Lobular Carcinoma in Situ (LCIS) of the breast
- •10. Concurrent chemotherapy or any previous HM
- •11. Any known allergy to either mitomycin or BCG, or previously withdrawn from BCG treatment due to a related adverse event (e.g., systemic infection)
- •12. Active or intractable urinary tract infection (UTI)
- •13. Urethral stricture, or any situation impending the insertion of a 20F catheter
- •14. Bladder diverticula >1 cm
- •15. Significant urinary incontinence
研究者
相似试验
已完成
3 期
Clinical trial to assess the importance of nephrectomyMetastatic renal cell carcinoma, clear cell carcinoma (the most common type of renal cell carcinoma).Malignant neoplasm of kidney, except renal pelvisCancerISRCTN19562321HS Greater Glagsow and Clyde (UK)450
已完成
3 期
A phase III, randomised, controlled trial for the treatment of HIV-associated cryptococcal meningitis: oral fluconazole plus flucytosine or one week amphotericin B-based therapy vs two weeks amphotericin B-based therapyISRCTN45035509St George's University of London (UK)680
已完成
3 期
A randomised, placebo-control phase III study to assess the safety and efficacy of the MPT64 patch test in the diagnosis of active tuberculosis (TB)Active pulmonary tuberculosis.Infections and InfestationsTuberculosisISRCTN49676555Sequella Inc (USA)512
已完成
3 期
CLEOPATRA study: the clinical efficacy and safety of light-masks at preventing dark adaptation in the treatment of non-centre-involving diabetic macular oedemaTopic: Diabetes Research Network, EyeSubtopic: Both, Other, Eye (all Subtopics)Disease: Retinopathy, Diabetic Control, Other, Retina (including diabetes)Nutritional, Metabolic, EndocrineISRCTN85596558Moorfields Eye Hospital NHS Foundation Trust (UK)300
已完成
不适用
Early Venous Reflux Ablation (EVRA) ulcer trialISRCTN02335796Imperial College London (UK)450