A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer


Condition: Infiltrating Bladder Urothelial Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01495676

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Exclusion Criteria:

  • Bladder tumors without any muscle infiltration
  • Epidermoid carcinoma or adenocarcinoma
  • Distance metastases or extrapelvic node positivity
  • Severe digestive history (ulcerative colitis, complicated diverticulitis)
  • Pregnancy and breast feeding

View trial on ClinicalTrials.gov