Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215071
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Association of Urologic Oncology (AUO)

Brief Summary:
This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: limited lymphadenectomy Procedure: extended lymphadenectomy Not Applicable

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 the prognostic role of regional lymphadenectomy.

Results of retrospective studies suggest, that the prognosis of patients with muscle-invasive bladder cancer can be improved by extending the limits of pelvic lymphadenectomy. Furthermore it could be demonstrated in a prospective study that the pattern of metastasis of bladder cancer has a high variability. About two-thirds of lymph node metastases are found outside the normally cleared areas of lymphadenectomy. In this study patients will be randomized into arms with limited versus extended lymphadenectomy.

The limited lymphadenectomy includes the removal of the obturatoric, external and internal iliac lymph nodes, the extended one includes the removal of all lymph nodes between pelvic floor and the inferior mesenteric artery. The primary objective of the study is to detemine the influence of limited versus extended lyphadenectomy at the time of radical cystectomy on recurrence-free survival. Secondary study objectives include the influence on cancer-specific survival, overall survival, complication rates, histopathologic N-stage, the localization of recurrence and influence of adjuvant chemotherapy . Adjuvant chemotherapy is optional and is recommended in patients with locally advanced disease (pT3/4) or regional lymph node metastasis (pN+).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
Study Start Date : February 2006
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: limited lymphadenectomy
Fields 5, 7, 9, 11, 13, 14 are removed
Procedure: limited lymphadenectomy
Field 5 (Group external iliac rigt) Field 7 (Group external iliac left) Field 9 (obturatorical Group right) Field 11 (obturatorical Group left) Field 13 (Group internal iliac right) Field 14 (Group internal iliac left)
Other Names:
  • eingeschränkte Lymphadenektomie
  • eingeschränkte LA

Experimental: extended lymphadenectomy
Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
Procedure: extended lymphadenectomy
Field 1 (paracaval right) Field 2 (interaortocaval) Field 3 (paraaortal left) Field 4 (Group iliac artery right) Field 5 (Group external iliac rigt) Field 6 (Group iliac artery left) Field 7 (Group external iliac left) Field 8 (presacral) Field 9 (obturatorical Group right) Field 10 (deep obturatorical Group right) Field 11 (obturatorical Group left) Field 12 (deep obturatorical Group left) Field 13 (Group internal iliac right) Field 14 (Group internal iliac left)
Other Names:
  • ausgedehnte Lymphadenektomie
  • ausgedehnte LA




Primary Outcome Measures :
  1. Recurrence free Survival (RFS) [ Time Frame: 5 years ]
    Definition Recurrence-free survival: Time from radical cystectomy to tumor reccurence or death from any cause up to 5 years


Secondary Outcome Measures :
  1. Cancer specific survival (CSS) [ Time Frame: 5 years ]
    Definition Cancer-specific suvival: Time from radical cystectomy to death from bladder cancer up to 5 years

  2. Overall survival (OS) [ Time Frame: 5 years ]
    Definition Overall survival: Time from radical cystectomy to death from any cause up to 5 years

  3. Determination of type and location of tumour progression(local recurrences and distant metastases) [ Time Frame: 5 years ]
  4. Effect on histopathological stage (Will Rogers phenomenon) [ Time Frame: 5 years ]
    Definition Effect on histopathologic stage: Influence of extended lymphadenectomy on detection of lymph node metastasis

  5. Influence of adjuvant chemotherapy (by subgroup analysis) [ Time Frame: 5 years ]
  6. Documentation of complications [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215071


Locations
Layout table for location information
Germany
Urological hospital, Städt. Kliniken Dortmund
Dortmund, Germany, 44145
Paracelsus Hospital
Düsseldorf, Germany, 40474
Heinrich Heine University
Düsseldorf, Germany
University of Essen
Essen, Germany, 45122
Department of urology, städt. Klinikum Fulda
Fulda, Germany, 36043
Saarland University
Homburg/Saar, Germany, 66421
Städt. Klinikum
Karlsruhe, Germany, 76133
Urological Hospital Kassel
Kassel, Germany, 34125
University of Cologne
Köln, Germany, 50937
Hospital Holweide
Köln, Germany, 51067
Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Otto von Guericke University
Magdeburg, Germany, 39120
Klinikum r. d. Isar der TUM
München, Germany, 81675
Eberhard Karls University
Tübingen, Germany, 72076
Urological hospital, University Hospital Ulm
Ulm, Germany, 89075
Helios Klinikum Wuppertal
Wuppertal, Germany, 42283
Sponsors and Collaborators
Association of Urologic Oncology (AUO)
Eli Lilly and Company
Investigators
Layout table for investigator information
Principal Investigator: Jürgen E. Gschwend, Prof. Dr. AUO - Association of Urologic Oncology
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Association of Urologic Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01215071    
Other Study ID Numbers: AB 25/02
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association of Urologic Oncology (AUO):
Lymphadenectomy
Extension
Bladder cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases