- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718741
Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer. (Bladder-Aid)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Milano
-
Rozzano, Milano, Italy, 20089
- Istituto Clinico Humanitas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adiuvant Radiotherapy +/- CT
The radiation treatment will be delivered with two possible schedules, according to the presence of positive margins on the pathology specimen:
Considering an alfa/beta of 10 for bladder tumor and 3 for healthy tissues the equivalent doses will be respectively: BED10: 60/67.1; EQD2: 50/55.92 Gy BED3: 83.33/95.33; EQD2: 50/57.20 Gy Patients with ECOG PS<2, good haematological, hepatic and renal function (haemoglobin, neutrophil count, platelets, creatinine, glycaemia, Bilirubin, AST, ALT values within the limits of normal), will be submitted to concurrent cisplatin based weekly chemotherapy, 20-30 mg/m2, if they have not received neoadjuvant chemotherapy before surgery. |
Adiuvant Radiotherapy +/- weekly cisplatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local Control Rate
Time Frame: 2 year
|
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.
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 2 years
|
Overall survival
|
2 years
|
PFS
Time Frame: 2 years
|
Progression Free Survival
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bladder Cancer
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | No Evidence of Disease | Stage II Bladder Cancer | Stage IVA Bladder Cancer | Stage IVB Bladder CancerUnited States
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H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Cancer | Urinary Complications | Stage 0 Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder Cancer
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Fox Chase Cancer CenterTerminatedStage III Bladder Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Squamous Cell Carcinoma of the Bladder | Urethral Cancer Associated With Invasive Bladder Cancer | Stage II Bladder CancerUnited States
-
National Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Stage II Bladder CancerUnited States
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Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
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Taris Biomedical LLCBristol-Myers SquibbTerminatedBladder Cancer TNM Staging Primary Tumor (T) T2 | Bladder Cancer TNM Staging Primary Tumor (T) T2A | Bladder Cancer TNM Staging Primary Tumor (T) T2B | Bladder Cancer TNM Staging Primary Tumor (T) T3 | Bladder Cancer TNM Staging Primary Tumor (T) T3A | Bladder Cancer TNM Staging Primary Tumor... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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University Health Network, TorontoCompleted
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