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Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

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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)

Tracking Information
First Submitted Date  ICMJE September 29, 2010
First Posted Date  ICMJE October 6, 2010
Last Update Posted Date January 24, 2018
Study Start Date  ICMJE February 2006
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
Progression free Survival [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2018)
  • 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
  • Overall survival (OS) [ Time Frame: 5 years ]
    Definition Overall survival: Time from radical cystectomy to death from any cause up to 5 years
  • Determination of type and location of tumour progression(local recurrences and distant metastases) [ Time Frame: 5 years ]
  • 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
  • Influence of adjuvant chemotherapy (by subgroup analysis) [ Time Frame: 5 years ]
  • Documentation of complications [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA
Official Title  ICMJE Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
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 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+).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: limited lymphadenectomy
    Fields 5, 7, 9, 11, 13, 14 are removed
    Intervention: Procedure: limited lymphadenectomy
  • Experimental: extended lymphadenectomy
    Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
    Intervention: Procedure: extended lymphadenectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2018)
401
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2010)
450
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01215071
Other Study ID Numbers  ICMJE AB 25/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Association of Urologic Oncology (AUO)
Study Sponsor  ICMJE Association of Urologic Oncology (AUO)
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Jürgen E. Gschwend, Prof. Dr. AUO - Association of Urologic Oncology
PRS Account Association of Urologic Oncology (AUO)
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP