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Prospective Multicentric Evaluation of a Bladder Preservation Strategy (ReChiVe)

Primary Purpose

Urothelial Carcinoma

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
optimal TURB
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring urothelial carcinoma, TURB, chemotherapy

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surgical resection and chemotherapy

Arm Description

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.

Outcomes

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).

Secondary Outcome Measures

proportion of complete response
Chemotherapy tolerance in a neoadjuvant setting using the intensified MVAC
Secondary cystectomy rate
Progression free survival (either infiltrative [≥ T2] or metastatic)
Overall bladder preservation rate
Overall survival

Full Information

First Posted
March 24, 2010
Last Updated
December 10, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT01093066
Brief Title
Prospective Multicentric Evaluation of a Bladder Preservation Strategy
Acronym
ReChiVe
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in the inclusion and follow-up of patients
Study Start Date
September 21, 2010 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
urothelial carcinoma, TURB, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgical resection and chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
optimal TURB
Intervention Description
The TURB will always try to be optically complete.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
proportion of complete response
Time Frame
6 months
Title
Chemotherapy tolerance in a neoadjuvant setting using the intensified MVAC
Time Frame
3 months
Title
Secondary cystectomy rate
Time Frame
6 months
Title
Progression free survival (either infiltrative [≥ T2] or metastatic)
Time Frame
5 years
Title
Overall bladder preservation rate
Time Frame
5 years
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas MOTTET, MD
Organizational Affiliation
clinique Mutualiste chirurgicale
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH du Pays d'Aix-en-Provence
City
Aix-en-Provence
Country
France
Facility Name
Clinique AXIUM - AIX EN PROVENCE
City
Aix-en-Provence
Country
France
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Clinique Saint-Augustin
City
Bordeaux
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Crlcc Francois Baclesse
City
Caen
ZIP/Postal Code
54500
Country
France
Facility Name
CHU Créteil
City
Créteil
Country
France
Facility Name
Polyclinique de Lisieux
City
Lisieux
Country
France
Facility Name
APHM - Marseille - Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13 385
Country
France
Facility Name
APHM - Marseille - Hôpital la Timone
City
Marseille
Country
France
Facility Name
CRLC Marseille
City
Marseille
Country
France
Facility Name
Hôpital Européen - Marseille
City
Marseille
Country
France
Facility Name
Hôpitaux privés de Metz
City
Metz
Country
France
Facility Name
Chu Nancy
City
Nancy
Country
France
Facility Name
Crlc Nancy
City
Nancy
Country
France
Facility Name
Chu Nantes
City
Nantes
Country
France
Facility Name
APHP - Saint-Louis
City
Paris
Country
France
Facility Name
APHP- Hôpital Tenon
City
Paris
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Chu Reims
City
Reims
Country
France
Facility Name
Institut Jean Godinot - Reims
City
Reims
Country
France
Facility Name
Clinique Mutualiste Chirurgicale
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
Facility Name
ICO - SITE Gauducheau - ICL Nantes
City
Saint-Herblain
ZIP/Postal Code
44 805
Country
France
Facility Name
ICLN
City
Saint-priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
Facility Name
Hôpitaux du Léman - Thonon-les-Bains
City
Thonon-les-Bains
Country
France
Facility Name
CHI Toulon
City
Toulon
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
INSTITUT CLAUDIUS REGAUD - CRLC Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Polyclinique Du Cotentin
City
Équeurdreville-Hainneville
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prospective Multicentric Evaluation of a Bladder Preservation Strategy

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