bladder infiltrative urothelium carcinoma MedDRA version: 12.0 Level: LLT Classification code 10005021 Term: Bladder carcinoma stage II
Conditions
Interventions
Product Name: Methotrexate
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: METHOTREXATE
CAS Number: 59-05-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Clinique Mutualiste Chirurgicale
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: proportion of complete response Overall bladder preservation rate Chemotherapy tolerance in a neoadjuvant setting using the intensified MVAC Progression free survival (either infiltrative [= T2] or metastatic) Secondary cystectomy rate Overall survival ;Primary end point(s): The primary efficacy criteria is the 5 years bladder preservation rate (with or without intravesical non muscle infiltrative recurrences, treated by TURB only or intravesical instillations of either BCG or mytomicine C).;Main Objective: the 5 years bladder preservation rate in patients with a localized infiltrative bladder treated with a double optimal transurethral bladder resection (TURB) combined with a neoadjuvant chemotherapy. | — |
Countries
France
Outcome results
None listed