Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
401 participants
INTERVENTIONAL
2006-02-28
2015-08-31
Brief Summary
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Detailed Description
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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+).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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limited lymphadenectomy
Fields 5, 7, 9, 11, 13, 14 are removed
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)
extended lymphadenectomy
Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
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)
Interventions
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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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
* Written consent of the patient
* Patient compliance and geographic proximity to allow adequate follow-up
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Association of Urologic Oncology (AUO)
OTHER
Responsible Party
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Principal Investigators
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Jürgen E. Gschwend, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
AUO - Association of Urologic Oncology
Locations
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University of Cologne
Cologne, , Germany
Hospital Holweide
Cologne, , Germany
Urological hospital, Städt. Kliniken Dortmund
Dortmund, , Germany
Paracelsus Hospital
Düsseldorf, , Germany
Heinrich Heine University
Düsseldorf, , Germany
University of Essen
Essen, , Germany
Department of urology, städt. Klinikum Fulda
Fulda, , Germany
Saarland University
Homburg/Saar, , Germany
Städt. Klinikum
Karlsruhe, , Germany
Urological Hospital Kassel
Kassel, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Otto von Guericke University
Magdeburg, , Germany
Klinikum r. d. Isar der TUM
München, , Germany
Eberhard Karls University
Tübingen, , Germany
Urological hospital, University Hospital Ulm
Ulm, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Countries
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References
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Gschwend JE, Heck MM, Lehmann J, Rubben H, Albers P, Wolff JM, Frohneberg D, de Geeter P, Heidenreich A, Kalble T, Stockle M, Schnoller T, Stenzl A, Muller M, Truss M, Roth S, Liehr UB, Leissner J, Bregenzer T, Retz M. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol. 2019 Apr;75(4):604-611. doi: 10.1016/j.eururo.2018.09.047. Epub 2018 Oct 15.
Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hubler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19.
Related Links
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The AUO Homepage where this study is presented
Other Identifiers
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AB 25/02
Identifier Type: -
Identifier Source: org_study_id
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