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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01093066
Other study ID # 0908038
Secondary ID 2009-014264-19
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 21, 2010
Est. completion date December 31, 2020

Study information

Verified date December 2021
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Radical cystectomy is the treatment of choice for bladder infiltrative urothelium carcinoma. But the removal of the bladder reservoir has a major impact of the Quality of life. Neoadjuvant chemotherapy has been shown to be associated with an absolute 5% survival benefit. Two monocentric studies suggest that this neoadjuvant chemotherapy could be used in combination with an optimal transurethral bladder resection, in a strategy of bladder preservation, provided a complete response being obtained (about 50% in every trial using neoadjuvant MVAC protocol before a radical cystectomy). In those both studies with patients T2 to T4, the 5 years overall survival is above 65%, with more than 40% bladder preservation rate at 5 years. The feasibility and the efficacy of such an attitude in a multicentric trail using the most active regimen (in term of complete response in metastatic patients) is unknown. The chosen regimen is therefore the intensified MVAC which allows, with the use of G-CSF, to double the dose-intensity of Adriamycin and Cisplatinum, and to decrease by 30% the methotrexate and vinblastine dose-intensity. The efficacy and safety confirmation of such an approach could lead to consider it in patients motivated to retain a functional bladder.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 77
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility 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, Creatinine 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

Study Design


Intervention

Drug:
optimal TURB
The TURB will always try to be optically complete.

Locations

Country Name City State
France CH du Pays d'Aix-en-Provence Aix-en-Provence
France Clinique AXIUM - AIX EN PROVENCE Aix-en-Provence
France CHU Bordeaux Bordeaux
France Clinique Saint-Augustin Bordeaux
France Institut Bergonie Bordeaux
France CHU Caen Caen
France Crlcc Francois Baclesse Caen
France CHU Créteil Créteil
France Polyclinique Du Cotentin Équeurdreville-Hainneville
France Polyclinique de Lisieux Lisieux
France APHM - Marseille - Hôpital de la Conception Marseille
France APHM - Marseille - Hôpital la Timone Marseille
France CRLC Marseille Marseille
France Hôpital Européen - Marseille Marseille
France Hôpitaux privés de Metz Metz
France Chu Nancy Nancy
France Crlc Nancy Nancy
France Chu Nantes Nantes
France APHP - Saint-Louis Paris
France APHP- Hôpital Tenon Paris
France CHU Poitiers Poitiers
France Chu Reims Reims
France Institut Jean Godinot - Reims Reims
France Clinique Mutualiste Chirurgicale Saint-etienne
France CHU Saint-Etienne Saint-Étienne
France ICO - SITE Gauducheau - ICL Nantes Saint-Herblain
France ICLN Saint-priest En Jarez
France Hôpitaux du Léman - Thonon-les-Bains Thonon-les-Bains
France CHI Toulon Toulon
France CHU Toulouse Toulouse
France INSTITUT CLAUDIUS REGAUD - CRLC Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 5 years
Secondary proportion of complete response 6 months
Secondary Chemotherapy tolerance in a neoadjuvant setting using the intensified MVAC 3 months
Secondary Secondary cystectomy rate 6 months
Secondary Progression free survival (either infiltrative [= T2] or metastatic) 5 years
Secondary Overall bladder preservation rate 5 years
Secondary Overall survival 5 years
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