Randomized phase III study of gemcitabine and cisplatin (GC) versus high dose intensity methotrexate, vinblastine, doxorubicin and cisplatin (HD-MVAC) in the perioperative setting for patients with locally advanced transitional cell cancer of the bladder. - VESPER

CHU-Hôpitaux de Rouen0 个研究点目标入组 500 人开始时间: 2012年9月4日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•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

•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.

发起方

CHU-Hôpitaux de Rouen