Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.

Inclusion Criteria:

• Histologically proven TCC of the urinary bladder. Mixed tumours comprisingpredominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma arealso eligible.

• Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm inmaximum dimension), N0, M0. If radiological evaluation of a lymph node is interpreted as "positive" this must beevaluated further by either lymph node sampling or percutaneous needle biopsy. Patientswith histologically confirmed lymph node metastases will not be eligible.

• Maximal TUR. N.B. Previous:

1. partial cystectomy;

2. endoscopic resection of bladder tumour/s;

3. intravesical chemotherapy; or

4. intravesical BCG does not exclude the patient from being eligible. However, the patient should have anadequate functioning bladder (this should be clarified with the referring Urologist and ifneed be voiding volumes should be measured).

• Creatinine clearance >= 50ml/minute by calculation or measurement.

• A white blood cell count >= 3.5 x 10^9/L with an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.

• ECOG status of 0, 1 or 2.

• No age limit applies provided the patient is mentally, physically and geographicallycapable of undergoing treatment and follow-up.

• No significant intercurrent morbidity.

Exclusion Criteria:

• Pure squamous carcinomas or adenocarcinomas.

• Extensive or multifocal CIS change in the bladder.

• T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension),T4b, node positive and metastatic disease.

• Presence of ureteric obstruction due to tumour infiltration at the UO not amenable tostenting.

• Previous radiation treatment to the pelvis.

• Previous significant pelvic surgery.

• Significant bowel or gynaecological inflammatory disease.

• Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cellcount < 3.5 x 10^9/L with an absolute neutrophil count < 1.5 x 10^9L and/or a plateletcount < 100 x 10^9/L.

• Other considerations making patient unfit for Cisplatin therapy.

• Prior or concurrent malignancy of any other site unless disease-free for greater than 5 years, except for:

1. non-melanoma skin cancer, and/or

2. (a) Stage T1 well differentiated prostatic carcinoma in men, and In situcarcinoma of the cervix in women.

• Bladder tumour - biopsy only. These patients must be referred back for more adequateresections or else should not be included