Status:
COMPLETED
Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA
Lead Sponsor:
Association of Urologic Oncology (AUO)
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.
Detailed Description
The extent of pelvic lymphadenectomy in the surgical treatment of muscle-invasive, clinically locally bladder cancer is not yet standardized. There are no data from randomized, prospective studies on ...
Eligibility Criteria
Inclusion
- Histologically proven, invasive urothelial bladder cancer, locally completely resectable (T1G3 - T4a, Nx)
- Age \>= 18 years
- Written consent of the patient
- Patient compliance and geographic proximity to allow adequate follow-up
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT01215071
Start Date
February 1 2006
End Date
August 1 2015
Last Update
January 24 2018
Active Locations (16)
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1
University of Cologne
Cologne, Germany, 50937
2
Hospital Holweide
Cologne, Germany, 51067
3
Urological hospital, Städt. Kliniken Dortmund
Dortmund, Germany, 44145
4
Paracelsus Hospital
Düsseldorf, Germany, 40474