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)
- Conditions
- on muscle invasive bladder cancerMedDRA version: 9.1 Level: LLT Classification code 10005006 Term: Bladder cancer stage 0, with cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005007 Term: Bladder cancer stage 0, without cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005008 Term: Bladder cancer stage I, with cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005009 Term: Bladder cancer stage I, without cancer in situ
- Registration Number
- EUCTR2008-005428-99-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 104
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method