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

Clinique Mutualiste Chirurgicale0 个研究点开始时间: 2009年11月26日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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

发起方