Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.

Condition: Bladder Cancer

Intervention:

• Radiation: Radiotherapy +/- CT

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03718741

Sponsor: Istituto Clinico Humanitas

Primary Outcome Measures:

• Measure: Local Control Rate
• Time Frame: 2 year
• Safety Issue:

Secondary Outcome Measures:

• Measure: PFS
• Time Frame: 2 years
• Safety Issue:
• Measure: OS
• Time Frame: 2 years
• Safety Issue:

Estimated Enrollment: 80

Study Start Date: February 5, 2019

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

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

Contact:

• Giuseppe D’Agostino, MD
• giuseppe.dagostino@humanitas.it
• +39 0282247301

Location:

• Istituto Clinico Humanitas
• Rozzano Milano 20089 Italy

View trial on ClinicalTrials.gov