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.

Phase 1

• Conditions: locally advanced transitional cell cancer of the bladder; MedDRA version: 15.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000563-25-FR
• Lead Sponsor: CHU-Hôpitaux de Rouen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-04
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified