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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to define the optimal management of localised transitional cell carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether chemoradiation is superior to radiotherapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborator: National Health and Medical Research Council, Australia
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Histologically proven TCC of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.

• Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm in maximum dimension), N0, M0.

If radiological evaluation of a lymph node is interpreted as "positive" this must be evaluated further by either lymph node sampling or percutaneous needle biopsy. Patients with 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 an adequate functioning bladder (this should be clarified with the referring Urologist and if need 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 geographically capable 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 to stenting.

• 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 cell count < 3.5 x 10^9/L with an absolute neutrophil count < 1.5 x 10^9L and/or a platelet count < 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 situ carcinoma of the cervix in women.

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