locally advanced transitional cell cancer of the bladder MedDRA version: 15.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: cisplatin
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Concentration unit: mg/m2 milligram(s)/square meter
Concentrat
Sponsors
CHU-Hôpitaux de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Primary tumor 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 =40 ml/min, •Patients covered by a social security scheme, •Patient having read the information sheet and signed the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: •Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuro-endocrine 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy in terms of progression-free survival at 3 years of the combination of gemcitabine and cisplatin (GC) versus high dose methotrexate, vinblastine, doxorubicin and cisplatin (HD-MVAC) as perioperative chemotherapy for locally advanced -transitional cell carcinoma of the bladder.;Secondary Objective: To assess toxicity (CTC AE v4.0) To assess response rate (RR) in patients treated in the neoadjuvant setting To assess overall survival (OS) To assess time to progression (TTP) To study the correlation between response rate, time to progression, overall survival and biological parameters. ;Primary end point(s): progression-free survival (PFS) in patients at 3 years ;Timepoint(s) of evaluation of this end point: Survival rates will be estimated according to Kaplan-Meier. The event times for the analysis of PFS will be calculated from the date of randomisation to the date of progression or death. Patients who do not progress nor die will be censored at the last visit date, or at the date of a secondary treatment initiation in the case of absence of progression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity (CTC AE v4.0) Response (RECIST criteria) Overall survival (OS) Time to progression (TTP) correlation with biological parameters focusing on gemcitabine and cisplatin sensitivity;Timepoint(s) of evaluation of this end point: 5 years | — |
Countries
France
Contacts
Public ContactChristian PFISTER
CHU-Hôpitaux de Rouen
Outcome results
None listed