Prospective randomized study to comparing an extended pelvic lymphadenectomy with a limited in the surgical treatment of bladder cancer - LEA - AB 25/02
Organizational Data
- DRKS-ID:
- DRKS00003394
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2012-01-20
- Last update in DRKS:
- 2012-04-05
- Registration type:
- Retrospective
Acronym/abbreviation of the study
LEA - AB 25/02
URL of the study
No Entry
Brief summary in lay language
This study is for patients with bladder cancer and indication for radically cystectomy. Using different strategies of lymphadenectomy it shell be evaluated if the extension of lymphadenectomy influences further progression of the disease.
Brief summary in scientific language
Study is meant to evaluate the influence of different extension of pelvic lymphadenectomy on outcome of patients with bladder cancer.
Health condition or problem studied
- ICD10:
- C67 - Malignant neoplasm of bladder
- Free text:
- bladder carcinoma
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- limited lymphadenectomy
- Arm 2:
- extended lymphadenectomy
Endpoints
- Primary outcome:
- Progression free Survival [ Time Frame: 5 years ]
- Secondary outcome:
- - Determination of type and location of tumour progression(local recurrences and distant metastases) [ Time Frame: 7 years ] - disease-specific survival [ Time Frame: 7 years ] - Influence of adjuvant chemotherapy (by subgroup analysis) [ Time Frame: 7 years ] - Documentation of complications [ Time Frame: 7 years ] - Effect on histopathological stage (Will Rogers phenomenon) [ Time Frame: 7 years ]
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Krankenhaus Holweide Köln
- University medical center Klinikum Kassel Kassel
- University medical center Städtisches Klinikum Karlsruhe Karlsruhe
- University medical center Helios Klinikum Wuppertal Wuppertal
- Medical center Klinik für Urologie und Kinderurologie Fulda
- University medical center Universität Düsseldorf-Urologie Düsseldorf
- University medical center UKK Köln
- University medical center Klinikum Ludwigshafen Urologie Ludwigshafen am Rhein
- University medical center Universitätsklinikum Essen Essen
- Medical center Urologische Klinik und Poliklinik Homburg
- Medical center Urologische Klinik Ulm
- University medical center Uniklinikum Magdeburg Magdeburg
- University medical center Universitätsklinikum Tübingen Urologie Tübingen
- University medical center St. Josefs-Hospital Dortmund Urologie Dortmund
- University medical center Klinikum rechts der Isar der TU München München
- Medical center Paracelsus Klinik Golzheim Düsseldorf
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2006-02-11
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 450
- Final Sample Size:
- 459
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 100 Years
- Additional Inclusion Criteria:
- - 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
Exclusion Criteria
- 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
Addresses
Primary Sponsor
- Address:
- Klinikum rechts der Isar der TU MünchenProf. Dr. med. Jürgen GschwendIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- 089 4140-1
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.tu-muenchen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinikum rechts der Isar der TU MünchenDr. Margitta RetzIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- 089 4140-1
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.tu-muenchen.de
Contact for Public Queries
- Address:
- Klinikum rechts der Isar der TU MünchenDr. Margitta RetzIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- 089 4140-1
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.tu-muenchen.de
Principal Investigator
- Address:
- Klinikum rechts der Isar der TU MünchenDr. Margitta RetzIsmaninger Str. 2281675 MünchenGermany
- Telephone:
- 089 4140-1
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.tu-muenchen.de
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Arbeitsgemeinschaft Urologische Onkologie (AUO) in der Deutschen Krebsgesellschaft e. V.Seestr. 1117252 SchwarzGermany
- Telephone:
- 039827/79 677
- Fax:
- 039827/9 678
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.auo-online.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43021581
- Fax:
- +49-211-43021585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2005-08-15
- Ethics committee number:
- 2005275
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2005-09-29
Further identification numbers
- Other primary registry ID:
- NCT01215071 - clinical-trials.gov
- EudraCT Number:
- No Entry
- Other secondary IDs:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry