Status:
COMPLETED
Perioperative Chemotherapy for Patients With Locally Advanced Bladder Cancer
Lead Sponsor:
University Hospital, Rouen
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at...
Eligibility Criteria
Inclusion
- Primary tumour of the bladder
- Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular variants are accepted if combined with TCC)
- Disease defined by a T2, T3 or T4a N0 (lymph node £ 10 mm on CT scan) M0 stadification for patients receiving neoadjuvant chemotherapy OR pT3 or pT4 OR pN+ whatever pT and M0 for patients receiving adjuvant chemotherapy
- 18 ≤ age ≤ 80 years
- General condition 0 or 1 as per the WHO scale
- Absence of previous chemotherapy for muscle-invasive disease
- Haematological function: Haemoglobin \> 11 g/dl, neutrophils ≥ 1500/mm3, platelets ≥ 100,000/mm3
- Liver function: Grade\* 0 ASAT and ALAT, grade\* 0 alkaline phosphatases, normal bilirubin
- Renal function: calculated (or measured) creatinine clearance ³ 40 ml/min - --- Patients covered by a social security scheme
- Patient having read the information sheet and signed the informed consent form.
Exclusion
- Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma
- Ventricular ejection fraction \< 50%
- History of cancer in the 5 years prior to entry in the trial other than basal cell skin cancer or in situ epithelioma of the cervix
- Male or female patients not agreeing to use an effective method of contraception throughout the duration of treatment and for 6 months after treatment discontinuation
- Pregnant women, or female subjects liable to become pregnant or currently breast-feeding,
- Patient already included in another therapeutic trial on an investigational medicinal product,
- Persons deprived of their freedom or under judicial protection (including guardianship)
- Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01812369
Start Date
February 1 2013
End Date
September 25 2023
Last Update
October 6 2025
Active Locations (1)
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1
UHRouen
Rouen, France, 76031