Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01812369
Status:
UNKNOWN
Last Update Posted:
2020-01-14
First Post:
2013-01-22
Brief Title:
Perioperative Chemotherapy for Patients With Locally Advanced Bladder Cancer
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Randomized Phase III Study of GemcitabineCisplatine GC Versus High-dose Intensity Methotrexate Vinblastine Doxorubicine and Cisplatin HD-MVAC in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VESPER
Brief Summary:
Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer TCC of the bladder In contemporary series specific survival rates are about 60 to 65 at 5 years decreasing for locally advanced disease to 45-50 in patients with nonorgan-confined lymph-node negative tumours and to 30-35 in patients with lymph node positive tumours Perioperative chemotherapy adjuvant ou neoadjuvant has been developed in order to improve these results Thanks to randomized trials and meta-analysis it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5 equating to a survival rate of 50 at 5 years for nonorgan-confined tumours However the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen methotrexate vinblastine doxorubicin and cisplatin in the metastatic setting As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease also a better efficacy of HD-MVAC can be suspected in the perioperative setting Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided before or after radical cystectomy Secondary endpoints include overall survival side effects response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity The total number of patients projected is 500 The number of patients is based on the median progression-free survival rate of 50 at 3 years observed in patients treated with GC standard arm A in the perioperative setting An absolute improvement of 10 HR074 is expected with HD-MVAC experimental arm B with a005 and b020 An interim analysis is planned after the occurrence of 174 events With an estimated uniform accrual rate of 140 patients per year for 35 years and exponential survival the final analysis is expected to occur 8 years after the start of the trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None