A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer (GETUGV04)

Institut du Cancer de Montpellier - Val d'Aurelle

Status

Terminated

Conditions

Infiltrating Bladder Urothelial Carcinoma

Treatments

Other: Radiation + cisplatin

Other: Radiation + cisplatin + gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01495676

2011-000408-17 (EudraCT Number)

GETUG V04

Details and patient eligibility

About

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/m². 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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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