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Prospective Multicentric Evaluation of a Bladder Preservation Strategy (ReChiVe)

This study is currently recruiting participants.
Verified September 2016 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093066
First Posted: March 25, 2010
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

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.


Condition Intervention Phase
Urothelial Carcinoma Drug: optimal TURB Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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). [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • proportion of complete response [ Time Frame: 6 months ]
  • Chemotherapy tolerance in a neoadjuvant setting using the intensified MVAC [ Time Frame: 3 months ]
  • Secondary cystectomy rate [ Time Frame: 6 months ]
  • Progression free survival (either infiltrative [≥ T2] or metastatic) [ Time Frame: 5 years ]
  • Overall bladder preservation rate [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]

Estimated Enrollment: 77
Study Start Date: September 2010
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgical resection and chemotherapy

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.

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

Detailed 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093066


Contacts
Contact: Nicolas MOTTET, MD nmottet@mutualite-loire.com

Locations
France
CH du Pays d'Aix-en-Provence Recruiting
Aix-en-Provence, France
Contact: Frédéric ARROUA, MD         
Principal Investigator: Frédéric ARROUA, MD         
Sub-Investigator: Sylvie CAILLERES, MD         
Sub-Investigator: Sophie NAHON, MD         
Clinique AXIUM - AIX EN PROVENCE Recruiting
Aix-en-Provence, France
Contact: Nabil DAOU, MD         
Principal Investigator: Nabil DAOU         
CHU Bordeaux Completed
Bordeaux, France, 33000
Clinique Saint-Augustin Recruiting
Bordeaux, France
Contact: Jean-Luc HOEPFFNER, MD         
Principal Investigator: Jean-Luc HOEPFFNER, MD         
Sub-Investigator: Pierre-Thierry PIECHAUD, MD         
Institut Bergonie Recruiting
Bordeaux, France
Contact: Nadine HOUÉDÉ, MD         
Principal Investigator: Nadine HOUÉDÉ, MD         
Sub-Investigator: Guilhem ROUBAUD, MD         
Sub-Investigator: Marine GROSS-GOUPIL, MD         
Sub-Investigator: Sylvestre LE MOULEC, MD         
CHU Caen Completed
Caen, France, 14000
Crlcc Francois Baclesse Recruiting
Caen, France, 54500
Contact: Florence JOLY-LOBBEDEZ, MD         
Principal Investigator: Florence JOLY-LOBBEDEZ, MD         
CHU Créteil Completed
Créteil, France
Polyclinique de Lisieux Recruiting
Lisieux, France
Contact: Jean-Marc LEFORT, MD         
Principal Investigator: Jean-Marc LEFORT, MD         
APHM - Marseille - Hôpital de la Conception Recruiting
Marseille, France, 13 385
Contact: Eric LECHEVALLIER, MD       elechevallier@ap-hm.fr   
Principal Investigator: Eric LECHEVALLIER, MD         
Sub-Investigator: Gilles KARSENTY, MD         
Sub-Investigator: Clémence TOULLEC, MD         
Sub-Investigator: Pierre Olivier FAIS, MD         
APHM - Marseille - Hôpital la Timone Recruiting
Marseille, France
Contact: Jean-Laurent DEVILLE, MD         
Principal Investigator: Jean-Laurent DEVILLE, MD         
Sub-Investigator: Sébastien SALAS, MD         
Sub-Investigator: Thank Khoa HUYNH, MD         
Sub-Investigator: Aurélie DUCOURNAU, MD         
Sub-Investigator: Marie MEURER, MD         
CRLC Marseille Recruiting
Marseille, France
Contact: Gwenaëlle GRAVIS, MD         
Principal Investigator: Gwenaëlle GRAVIS, MD         
Sub-Investigator: MAGALI PROVANSAL, MD         
Sub-Investigator: Jochen WALZ, MD         
Hôpital Européen - Marseille Recruiting
Marseille, France
Contact: Julien DETURMENY, MD         
Principal Investigator: Julien DETURMENY, MD         
Sub-Investigator: Philippe DALIVOUST, MD         
Sub-Investigator: Aurélien CARCENAC, MD         
Sub-Investigator: Vincent GRISONI, MD         
Hôpitaux privés de Metz Completed
Metz, France
Chu Nancy Completed
Nancy, France
Crlc Nancy Completed
Nancy, France
Chu Nantes Completed
Nantes, France
APHP - Saint-Louis Recruiting
Paris, France
Contact: Stephane Culine, MD         
Principal Investigator: Stephane Culine, MD         
Sub-Investigator: Hélène GAUTHIER, MD         
Sub-Investigator: Damien Pouessel, MD         
Sub-Investigator: Camille SERRATE, MD         
Sub-Investigator: Pierre Mongiat Artus, MD         
Sub-Investigator: Armaury De GOUVELLO, MD         
APHP- Hôpital Tenon Completed
Paris, France
CHU Poitiers Completed
Poitiers, France, 86000
Chu Reims Recruiting
Reims, France
Contact: Stéphane LARRE, MD         
Principal Investigator: Stéphane LARRE, MD         
Institut Jean Godinot - Reims Recruiting
Reims, France
Contact: Jean-Christophe EYMARD, MD         
Principal Investigator: Jean-Christophe EYMARD, MD         
Clinique Mutualiste Chirurgicale Recruiting
Saint-etienne, France, 42055
Contact: Nicolas MOTTET, MD       nmottet@mutualite-loire.com   
Principal Investigator: Bertrand LACROIX, MD         
Sub-Investigator: Grégory DELORME, MD         
Sub-Investigator: Stéphane LORIN, MD         
Sub-Investigator: Renaud LARDON, MD         
ICO - SITE Gauducheau - ICL Nantes Completed
Saint-Herblain, France, 44 805
ICLN Recruiting
Saint-priest En Jarez, France, 42270
Contact: Aline GUILLOT, MD       aline.guillot@icloire.fr   
Principal Investigator: Aline GUILLOT, MD         
Sub-Investigator: Olivier COLLARD, MD         
Sub-Investigator: Romain RIVOIRARD, MD         
Sub-Investigator: Cécile VASSAL, MD         
CHU Saint-Etienne Recruiting
Saint-Étienne, France
Contact: Nicolas Mottet, MD         
Principal Investigator: Nicolas Mottet, MD         
Sub-Investigator: Frédéric Obadia, MD         
Sub-Investigator: Grégory Badin, MD         
Sub-Investigator: Jean-Etienne Terrier, MD         
Sub-Investigator: Nargisse Talji, MD         
Sub-Investigator: Amandine Croux, MD         
Sub-Investigator: Sylvain Piqueres, MD         
Hôpitaux du Léman - Thonon-les-Bains Completed
Thonon-les-Bains, France
CHI Toulon Recruiting
Toulon, France
Contact: Pierre-Olivier FAIS, MD         
Principal Investigator: Pierre-Olivier FAIS, MD         
Sub-Investigator: Pierre GUILLET, MD         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Michel SOULIE, MD       soulie.m@chu-toulouse.fr   
Principal Investigator: Michel SOULIE, MD         
Sub-Investigator: Matthieu THOULOUZAN, MD         
Sub-Investigator: Olivier MERIGOT de TREIGNY, MD         
Sub-Investigator: Mathieu ROUMIGUIE, MD         
INSTITUT CLAUDIUS REGAUD - CRLC Toulouse Recruiting
Toulouse, France, 31059
Contact: Christine CHEVREAU, MD         
Principal Investigator: Christine CHEVREAU, MD         
Sub-Investigator: Sarah BETRIAN-LAGARDE, MD         
Sub-Investigator: Audrey RABEAU, MD         
Sub-Investigator: Ewa-Anna COTTURA, MD         
Sub-Investigator: Loïc MOUREY, MD         
Sub-Investigator: Cécile GANDY, MD         
Sub-Investigator: Damien POUESSEL, MD         
Sub-Investigator: Thibaud VALENTIN, MD         
Polyclinique Du Cotentin Recruiting
Équeurdreville-Hainneville, France
Contact: Fabrice DUGARDIN, MD         
Principal Investigator: Fabrice DUGARDIN, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Nicolas MOTTET, MD clinique Mutualiste chirurgicale
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01093066     History of Changes
Other Study ID Numbers: 0908038
2009-014264-19 ( EudraCT Number )
First Submitted: March 24, 2010
First Posted: March 25, 2010
Last Update Posted: July 28, 2017
Last Verified: September 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
urothelial carcinoma
TURB
chemotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms