NON MUSCULAR INVASIVE BLADDER CANCER WITH INTERMEDIATE RISK OF RECURRENCE
Conditions
Interventions
Trade Name: MITOMYCIN-C
Product Name: MITOMYCIN C
Pharmaceutical Form: Intravesical solution
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
COMBAT MEDICAL LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New or Recurrence of intermediate risk NMIBC following TURBT defined as; ? Grade 2 or grade 1 stage T1 disease ? Any grade G2 or G1 other than Low risk 2. Age ? 18 yrs 3. WHO performance status 0, 1, 2, 3 4. Normal kidneys and ureters on imaging study within the past 12 months** 5. Pre-treatment haematology and biochemistry values within acceptable limits: - haemoglobin ? 10 g/dl - neutrophil count ? 1.5 x 109/l - platelets ? 100 x 109/l - WBC ? 3.0 x 109/l or ANC ? 1.5 x 109/l - Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Patients with any of the following conditions: - Grade 3 UCC. - CIS - Primary Solitary Ta G1<3cm - Primary Solitary Ta G2 <3cm 2. ?T2 UCC 3. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR. 4. History of limited vesical capacity (<200cc) 5. UCC involving the prostatic urethra or upper urinary tract. 6. Known allergy to MMC 7. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception. 8. 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 prostate cancer with less than 5yrs life expectancy. 9. Patients with tumours histologically different tan transitional cell carcinoma 10. Concurrent chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the efficacy in terms of disease-free survival after 24 months of follow of hyperthermic vs. non hyperthermic intravesical instillation with Mitomycin;Secondary Objective: To compare the tolerability, recurrence rate, time to progression and quality of life after 24 months of follow up, of hyperthermic vs non hyperthermic intravesical chemotherapy;Primary end point(s): EFFICACY PARAMETERS ? Disease-free survival ? Recurrence rate ? Time to progression;Timepoint(s) of evaluation of this end point: Cystoscopy at the end of the treatment and at 4, 8, 12, 18 and 24 months of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety Parameters - Dysuria, Urinary frequency, nocturia by IPSS scale - Graded visual pain scale (VAS) - Others reported by the health professional - EORTC Quality of Life Questionnaire QLQ-BLS24;Timepoint(s) of evaluation of this end point: ? Before each new instillation: the patient will report any side effect occurred from the last instillation. ? After the instillation: - the patient will report any side effect occurred during the present instillation. - healthcare professional will report any other side effect occurred during the present instillation. ? The quality of life questionnaire will be completed by the patients before receiving adjuvant treatment and repeated in the last study visit. | — |
Countries
Spain
Contacts
Public ContactDR. ALEJANDRO SOUSA ESCANDÓN
HOSPITAL COMARCAL DE MONFORTE
Outcome results
None listed