Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03718741 |
Other study ID # |
2107 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 5, 2019 |
Est. completion date |
March 9, 2022 |
Study information
Verified date |
May 2022 |
Source |
Istituto Clinico Humanitas |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This prospective interventional study aims at evaluating the safety and efficacy of an
adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical
cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.
Description:
Bladder cancer represents the ninth neoplasm in the world, with approximately 430,000 new
cases diagnosed in 2012. Of them, around 118,000 were diagnosed in Europe, and 52,000 had
died from this disease.
Patients with advanced bladder cancer (stage ≥pT3) have a five-year overall survival of ~50%
after cystectomy and pelvic lymphadenectomy +/- chemotherapy with approximately half of
recurrences in the pelvis, either as isolated failures or synchronous with distant
metastases. In fact, radical cystectomy with or without chemotherapy has a 5-year overall
survival of approximately 60% for patients with pathologic T2 disease confined to the bladder
but only 10-40% for stage ≥pT3 when disease extends into the extravesicular tissues.
Pelvic failures after radical cystectomy are common, especially for ≥pT3 urothelial carcinoma
with a cumulative incidence of locoregional failure of 32% at 5 years in the SWOG 8710
cohort. Adjuvant radiation therapy (RT) can reduce locoregional failure and may even improve
overall survival, but currently has no defined role, in part because of toxicity reported in
older series using 1980s radiation techniques.
An externally validated risk stratification to identify patients at highest risk for
local-regional failure who are most likely to benefit from adjuvant RT has been developed
based on pathologic T-stage, surgical margin status, and extent of the lymph node dissection.
Local-regional recurrence following radical cystectomy for patients with locally advanced
urothelial carcinoma is common. The risk of local-regional recurrence is not diminished with
chemotherapy, and salvage treatment is rarely successful. Adjuvant RT can reduce locoregional
failure and may even improve overall survival, but currently has no defined role, in part
because of toxicity reported in older series using 1980s radiation techniques. Several lines
of evidence support the hypothesis that improved local control may lead to improved
disease-free and overall survival.
This prospective interventional study aims at evaluating the safety and efficacy of an
adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical
cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.