Prospective Multicentric Evaluation of a Bladder Preservation Strategy Using a Combination of Neoadjuvant Chemotherapy and Optimal Bladder Transurethral Resection in Patients With a Urothelial Carcinoma
18 Years
69 Years
Both
Urothelial Carcinoma
Trial Information
Prospective Multicentric Evaluation of a Bladder Preservation Strategy Using a Combination of Neoadjuvant Chemotherapy and Optimal Bladder Transurethral Resection in Patients With a Urothelial Carcinoma
Every patient having signed the inform consent will have the following steps Maximal and
optimal TURB using a standardized procedure. The TURB will always try to be optically
complete.
Neoadjuvant chemotherapy for 3 months with the intensified MVAC (6 cycles administered every
2 weeks): METHOREXATE: 30 mg/m2 D1 - VINBLASTINE: 3 mg/m2 D2 - ADRIAMYCINE 30 mg/m2 D2 -
CISPLATINE 70 mg/m2 D2. + G-CSF: 5 µg/kg from D4 to D10 New maximal standardized TURB at
the end of the chemotherapy. In case of a lesion localized at the bladder dome, and if a
maximal TURB appears to be unsafe, a partial cystectomy without lymph node dissection will
be performed.
If a complete response is obtained (no tumor cells in the bladder muscle on the last TURB),
a surveillance will be proposed without any further treatment.
Otherwise (tumor cells in the bladder muscle at the second TURB), a radical cystectomy will
be done.
If the balder is spared, the follow up will be as follow: clinical examination, CT, bladder
endoscopy and urinary cytology every 6 months. The possible non muscle infiltrative bladder
relapses will be treated according
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 70 years of age PS
status ≤ 2 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 tauraco-abdomina-pelvic CT scan (no node > 1 cm) and bone scan.
Normal biological values: neutrophils > 1,5.109 /l, platelets > 100. 109 /l, Alkaline
Phosphatases < 2 x N, bilirubin < 1,5 N, Transaminases < 1,5 x N, Créatinine clearance ≥
60 ml/min Signed inform consent Patient belonging to a social security system.
Exclusion Criteria:
All other histology 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 (prostatitis) Serious
cardiac, pulmonary, hepatitic, renal, digestive or neurological pathology which is
non equilibrating or potential aggravating risk by treatment Cancer history or other
actual cancer (except 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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 mytomicin C).
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Nicolas MOTTET, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
clinique Mutualiste chirurgicale
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
0908038
NCT ID:
NCT01093066
Start Date:
September 2010
Completion Date:
December 2020
Related Keywords:
- Urothelial Carcinoma
- urothelial carcinoma
- TURB
- chemotherapy
- Carcinoma
- Carcinoma, Transitional Cell
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