Status:
TERMINATED
A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Infiltrating Bladder Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 i...
Detailed 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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01495676
Start Date
July 6 2011
End Date
December 7 2024
Last Update
October 10 2025
Active Locations (12)
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1
Institut Bergonié
Bordeaux, France, 33000
2
Centre Francois Baclesse
Caen, France, 14000
3
Hopital Henri Mondor
Créteil, France, 94010
4
CRLC GF Leclerc
Dijon, France, 21000