Hyperthermic Intra-Vesical Chemotherapy

Inclusion Criteria:

1. New or Recurrence of intermediate risk NMIBC following TURBT defined as;

• Grade 2 or grade 1 stage Ta or T1 disease*.

• Any grade G2 or G1 other than Low risk

2. Age ≥ 18 yrs

3. WHO performance status 0, 1, 2, 3

4. Pre-treatment haematology and biochemistry values within acceptable limits:

• Haemoglobin > or =10 g/dL

• Neutrophil count > or =1.5 x 109/L

• Platelets > or = 100 x 109/L

• WBC > or = 3.0 x 109/L or ANC > or = 1.5 x 109/L

• Serum creatinine < 1.5 x UNL

5. Negative pregnancy test for women of child-bearing potential.

6. Available for long-term follow-up.

7. Females of childbearing potential and males must be willing to use an effectivemethod of contraception (hormonal or barrier method of birth control; abstinence)from the time consent is signed until 6 weeks after treatment discontinuation.

8. Written informed consent.

Exclusion Criteria:

1. Grade 3 TCC

2. Carcinoma in situ.

3. New solitary Ta G1 (small)

4. New solitary Ta G2 (small)

5. Previous intravesical chemotherapy in the past 6 months, other than singleinstillation post-TUR.

6. Bladder capacity <200cc.

7. UCC involving the prostatic urethra or upper urinary tract.

8. > or =T2 UCC

9. Known allergy to mitomycin

10. Pregnant or lactating women or women of childbearing potential unwilling or unableto use adequate non-hormonal contraception.

11. Other malignancy within the past five years, except: non-melanomatous skin cancercured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCISof the breast or prostate cancer with more than 5yrs life expectancy or any nonlifethreatening tumours that have been curatively treated.

12. Concurrent chemotherapy.