None listed
Conditions
Brief summary
Radiation and chemotherapy both work in people with muscle-invasive bladder cancer. This study will determine if giving them together improves the results for people with this disease that seems to be confined to the bladder, but who are felt to be suitable candidates for bladder preserving treatment.
Interventions
ARM A: Synchronous chemo/radiation therapy. Weekly infusional cisplatin 35mg/m sqaured x 6 doses plus radiation 64Gy/32 fractions over 6 1/2 weeks.
Sponsors
Kumar Gogna
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven Transitional Cell Carcinoma (TCC) of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible. 2. 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. 3. Maximal Trans Urethral Resection (TUR). N.B. Previous: a) partial cystectomy; b) endoscopic resection of bladder tumour/s; c) intravesical chemotherapy; or d) intravesical Bacillus Calmette-Guerin (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). 4. Creatinine clearance >= 50ml/minute by calculation or measurement. 5. A white blood cell count >= 3.5 x 109/L with an absolute neutrophil count >= 1.5 x 109/L and a platelet count >= 100 x 109/L 6. Eastern Cooperative Oncology Group status of 0, 1 or 2. 7. No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up. 8. No significant intercurrent morbidity.
Exclusion criteria
1. Pure squamous carcinomas or adenocarcinomas. 2. Extensive or multifocal Carcinoma In Situ (CIS) change in the bladder. 3. T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease. 4. Presence of ureteric obstruction due to tumour infiltration at the Ureteral Orifice (UO) not amenable to stenting. 5. Previous radiation treatment to the pelvis. 6. Previous significant pelvic surgery. 7. Significant bowel or gynaecological inflammatory disease. 8. Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 109/L with an absolute neutrophil count < 1.5 x 109L and/or a platelet count < 100 x 109/L. 9. Other considerations making patient unfit for Cisplatin therapy. 10. 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 b) In situ carcinoma of the cervix in women. 11. Bladder tumour – biopsy only. These patients must be referred back for more adequate resections or else should not be included.
Outcome results
None listed