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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2025
  • participants needed
    108
  • sponsor
    Institut du Cancer de Montpellier - Val d'Aurelle
Updated on 22 August 2021

Summary

If radical cystectomy remains the standard of care for muscle invasive bladder cancer, consequences of this surgical procedure are often harsh. Over the past years, concurrent chemo-radiotherapy has imposed itself as an alternative treatment. Published data on concomitant radiochemotherapy (radiotherapy/cisplatin or radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer activities on urothelial diseases and has a synergetic activity with cisplatin. The investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m. The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.

Description

The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.

Details
Condition Infiltrating Bladder Urothelial Carcinoma
Treatment Radiation + cisplatin, Radiation + cisplatin + gemcitabine
Clinical Study IdentifierNCT01495676
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
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