ISRCTN85785327
Terminated
Phase 3
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 sites242 target enrollmentMay 28, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London (UK)
- Enrollment
- 242
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
- 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30274699
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Clinical trial to assess the importance of nephrectomyMetastatic renal cell carcinoma, clear cell carcinoma (the most common type of renal cell carcinoma).CancerMalignant neoplasm of kidney, except renal pelvisISRCTN19562321HS Greater Glagsow and Clyde (UK)450
Completed
Phase 3
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
Completed
Phase 3
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
Completed
Phase 3
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
Completed
Not Applicable
Early Venous Reflux Ablation (EVRA) ulcer trialISRCTN02335796Imperial College London (UK)450