Clinical trial NCT03718741: Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.
Official title: Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adiuvant Radiotherapy +/- CT
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Karnofsky index \> 60 % (ECOG \< 2)
* Histologically confirmed muscle-invasive bladder cancer (MIBC) submitted to radical cystectomy.
* Pathological T-stage \> pT3, and/or pathological N-stage \> pN1, and/or residual tumor present after surgery (R\>1)
* No distant metastases
* Written informed consent

Exclusion Criteria:

* Prior RT in the pelvic region
* Presence of distant metastases
* Pregnancy
* Inability to consent

Primary outcomes:
measure: Local Control Rate
timeFrame: 2 year
Secondary outcomes:
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
References: