HYMN: a trial comparing hyperthermia and mitomycin chemotherapy with a second BCG treatment, or other standard treatment, for bladder cancer that has come back
- Conditions
- on-muscle invasive bladder cancerCancerMalignant neoplasm of bladder
- Registration Number
- ISRCTN85785327
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30274699
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 242
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method