Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01812369
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01812369
Study Brief:
Protocol Section:
NCT01812369