Prospective multicentric evaluation of a bladder preservation strategy using a combination of neoadjuvant chemotherapy with intensified MVAC (Méthotrexate + vinblastine + adriamicine + Cisplatine) and optimal bladder transurethral resection in patients with a localized muscle infiltrative urothelial carcinoma (protocol ReChiVe) - ReChiVe

Conditions: bladder infiltrative urothelium carcinoma
MedDRA version: 12.0Level: LLTClassification code 10005021Term: Bladder carcinoma stage II

Registration Number: EUCTR2009-014264-19-FR

Lead Sponsor: Clinique Mutualiste Chirurgicale

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

T2 clinical stage (no palpable mass under anesthesia after TURB)
Absence of diffuse Cis (Cis on random bladder biopsies)
Patients above 18, and below 75 years of age
PS status = 1
No previous treatment for a bladder muscle infiltrative carcinoma. Previous endovesical instillations for non muscle infiltrative lesions (pTa, pT1, Cis) are allowed.
No metastases on thoraco-abdomino-pelvic CT scan (no node > 1 cm) and bone scan.
Normal biological values: neutrophils > 1,5.109 /l, platellets > 100. 109 /l, Alcaline Phosphatases < 2 x N, bilirubine < 1,5 N, Transaminases < 1,5 x N, Créatinine clairance = 60 ml/min
Signed inform consent
Patient belonging to a social security system.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All other histologia than urothelial carcinoma:
- primitive adenocarcinoma
- epidermoid carcinoma
- little cells carcinoma
In situ diffuse carcinoma associated with urothelial carcinoma muscular infiltrating
Tumor stade > T2, T3 or T4 or pT4a (prostatis)
Serious cardiac, pulmonary, hepathitic, renal, digestive or neurological pathology which is non equilibrating or potenbtial aggravating risk by treatment
Cancer history or other actual cancer (exept skin cancer) not remission or with an end of treatment inferior to 2 years
Participation to another clinical trial in a delay inferior to 30 days