NCT01093066: ReChiVe

Prospective Multicentric Evaluation of a Bladder Preservation Strategy

Terminated Phase 2 Last updated 30 December 2021

What this trial tests

Phase 2 trial testing optimal TURB in Urothelial Carcinoma in 77 participants. Terminated before completion.

Timeline

21 September 2010

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	77
Start date	21 September 2010
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	31 locations across France

Drugs / interventions tested

• optimal TURB — full drug profile →

Conditions studied

• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

Adults 18 to 69, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: Chemotherapy with immunogenic cell death inducers.
   Vacchelli E, Galluzzi L, Fridman WH, Galon J, et al · · 2012 · cited 98× · PMID 22720239 · DOI 10.4161/onci.1.2.19026
2. Current therapeutic strategies for invasive and metastatic bladder cancer.
   Vishnu P, Mathew J, Tan WW. · · 2011 · cited 35× · PMID 21792316 · DOI 10.2147/ott.s22875
3. Efficiency of bladder-sparing strategies for bladder cancer: an umbrella review.
   Li DX, Yu QX, Wu RC, Wang J, et al · · 2024 · cited 4× · PMID 38736553 · DOI 10.1177/17588359241249068