Trans Tasman Radiation Oncology Group (TROG) 02.03 - Multicentre Phase III study comparing Radical Synchronous Chemo-Radiation (cisplatin) vs Radical Radiation Alone in the Definitive Management of Muscle Invasive Transitional Cell Carcinoma (TCC) of the Urinary Bladder Following Maximal Trans-Urethral Resection to reduce invasive local failure.

Kumar Gogna0 个研究点目标入组 150 人开始时间: 2003年12月22日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Kumar Gogna