Prospective randomized study to comparing an extended pelvic lymphadenectomy with a limited in the surgical treatment of bladder cancer - LEA - AB 25/02
- Conditions
- bladder carcinomaC67Malignant neoplasm of bladder
- Registration Number
- DRKS00003394
- Lead Sponsor
- Klinikum rechts der Isar der TU München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 459
Histologically, muscle-invasive bladder cancer, locally completely resectable(T2 - T4a, Nx)
- Written consent of the patient
- Patient compliance and geographic proximity to allow adequate follow-up
- Histologically or by imaging diagnostics proven organ metastases
- Radiographic evidence of enlarged lymph nodes (> 1 cm) above the aortic bifurcation in conjunction with pelvic lymph node metastases
- Radiographic or other evidence of T4b-tumor (infiltration of the pelvic wall or other organ systems)
- Prior neoadjuvant chemotherapy of bladder cancer
- Prior previous pelvic lymphadenectomy
- Prior radiotherapy to the pelvis
- internal medical or anesthetic risk factors that require a short operation time
- Palliative cystectomy (f.e. bulky-disease, infiltration of adjacent structures)
- Evidence of another tumor restricting life expectancy of the patient
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free Survival [ Time Frame: 5 years ]
- Secondary Outcome Measures
Name Time Method - Determination of type and location of tumour progression(local recurrences and distant metastases) [ Time Frame: 7 years ]<br>- disease-specific survival [ Time Frame: 7 years ] <br>- Influence of adjuvant chemotherapy (by subgroup analysis) [ Time Frame: 7 years ]<br>- Documentation of complications [ Time Frame: 7 years ]<br>- Effect on histopathological stage (Will Rogers phenomenon) [ Time Frame: 7 years ]<br>