Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

• ClinicalTrials.gov Identifier: NCT01215071
• Recruitment Status: Completed
• First Posted: October 6, 2010
• Last Update Posted: January 24, 2018
• Sponsor: Association of Urologic Oncology (AUO)
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Association of Urologic Oncology (AUO)

Study Description

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+).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Jürgen E. Gschwend, Prof. Dr.; AUO - Association of Urologic Oncology

More Information

Additional Information:

The AUO Homepage where this study is presented 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gschwend JE, Heck MM, Lehmann J, Rübben H, Albers P, Wolff JM, Frohneberg D, de Geeter P, Heidenreich A, Kälble T, Stöckle M, Schnöller T, Stenzl A, Müller 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, Hübler 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.

• Responsible Party: Association of Urologic Oncology (AUO)
• ClinicalTrials.gov Identifier: NCT01215071
• Other Study ID Numbers: AB 25/02
• First Posted: October 6, 2010
• 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

Keywords provided by Association of Urologic Oncology (AUO):

Lymphadenectomy; Extension; Bladder cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases