Prospective Multicentric Evaluation of a Bladder Preservation Strategy (ReChiVe)
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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 |
Procedure: optimal TURB |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: No ]
- proportion of complete response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Chemotherapy tolerance in a neoadjuvant setting using the intensified MVAC [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Secondary cystectomy rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Progression free survival (either infiltrative [≥ T2] or metastatic) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall bladder preservation rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 77 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2015 (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. |
Procedure: 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| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Nicolas MOTTET, MD | nmottet@mutualite-loire.com |
| France | |
| RAVAUD Alain | Recruiting |
| Bordeaux, France, 33000 | |
| Contact: Alain RAVAUD, MD alain.ravaud@chu-bordeaux.fr | |
| Principal Investigator: Alain RAVAUD, MD | |
| Principal Investigator: Hervé WALLERAND, MD | |
| Henri BENSADOUN | Recruiting |
| Caen, France, 14000 | |
| Contact: Henri BENSADOUN, Dr | |
| Principal Investigator: Henri BENSADOUN, Dr | |
| Principal Investigator: Florence JOLY-LOBBEDEZ, MD | |
| Eric LECHEVALLIER | Recruiting |
| Marseille, France, 13 385 | |
| Contact: Eric LECHEVALLIER, Dr elechevallier@ap-hm.fr | |
| Principal Investigator: Eric LECHEVALLIER, Dr | |
| RIGAUD Jérôme | Recruiting |
| Nantes, France | |
| Contact: Jérôme RIGAUD, Dr jrigaud@chu-nantes.fr | |
| Principal Investigator: Jérôme RIGAUD, Dr | |
| IRANI Jacques | Recruiting |
| Poitiers, France, 86000 | |
| Contact: Jacques IRANI, Dr j.irani@chu-poitiers.fr | |
| Principal Investigator: Jacques IRANI, Dr | |
| Principal Investigator: B DORE, Pr | |
| Clinique Mutualiste Chirurgicale | Recruiting |
| Saint-etienne, France, 42055 | |
| Contact: Nicolas MOTTET, Dr nmottet@mutualite-loire.com | |
| Principal Investigator: Nicolas MOTTET, Dr | |
| BOMPAS Emmanuelle | Recruiting |
| Saint-herblain, France, 44 805 | |
| Contact: Emmanuelle BOMPAS, MD e-bompas@nantes.fnclcc.fr | |
| Principal Investigator: Emmanuelle BOMPAS, MD | |
| GUILLOT Aline | Recruiting |
| Saint-priest En Jarez, France, 42270 | |
| Contact: Aline GUILLOT, MD aline.guillot@icloire.fr | |
| Principal Investigator: Aline GUILLOT, MD | |
| CHEVREAU Christine | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Christine CHEVREAU, MD | |
| Principal Investigator: Christine CHEVREAU, MD | |
| SOULIE Michel | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Michel SOULIE soulie.m@chu-toulouse.fr | |
| Principal Investigator: Michel SOULIE, Pr | |
| GEOFFROY Lionel | Recruiting |
| Vandoeuvre Les Nancy, France, 54500 | |
| Contact: Lionel GEOFFROY, MD l.geoffrois@nancy.fnclcc.fr | |
| Principal Investigator: Florence JOLY-LOBBEDEZ, MD | |
| Principal Investigator: | Nicolas MOTTET, MD | clinique Mutualiste chirurgicale |
More Information
No publications provided
| Responsible Party: | Clinique Mutualiste Chirurgicale de la Loire |
| ClinicalTrials.gov Identifier: | NCT01093066 History of Changes |
| Other Study ID Numbers: | 0908038, 2009-014264-19 |
| Study First Received: | March 24, 2010 |
| Last Updated: | April 24, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
Keywords provided by Clinique Mutualiste Chirurgicale de la Loire:
|
urothelial carcinoma TURB chemotherapy |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013