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

Arm | Intervention/treatment |
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Experimental: limited lymphadenectomy
Fields 5, 7, 9, 11, 13, 14 are removed
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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:
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Experimental: extended lymphadenectomy
Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
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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:
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- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Jürgen E. Gschwend, Prof. Dr. | AUO - Association of Urologic Oncology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphadenectomy Extension Bladder cancer |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |