Randomized Phase III Study of Gemcitabine/Cisplatine (GC) Versus High-dose Intensity Methotrexate, Vinblastine, Doxorubicine and Cisplatin (HD-MVAC) in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder
Inclusion Criteria:
- 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 Criteria:
- 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.