A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer

Inclusion Criteria

• •Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed
• •The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.
• •Age ≥ 18 years
• •Life expectancy ≥ 6 months
• •Kanorfsky index ≥ 70 % (WHO 0, 1, 2)
• •Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance \> 60 ml/mn
• •No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)
• •Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.
• •No radiotherapy or chemotherapy history except for in situ bladder lesions.
• •No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer
• •No contraindication to gemcitabine or cisplatin.
• •No contraindication to radiotherapy
• •Information letter and informed consent signed
• •Patient covered by social security