Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: limited lymphadenectomy; Procedure: extended lymphadenectomy

• Registration Number: NCT01215071
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
limited lymphadenectomy	limited lymphadenectomy	Fields 5, 7, 9, 11, 13, 14 are removed
extended lymphadenectomy	extended lymphadenectomy	Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed

Primary Outcome Measures

Name	Time	Method
Recurrence free Survival (RFS)	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

Name	Time	Method
Cancer specific survival (CSS)	5 years	Definition Cancer-specific suvival: Time from radical cystectomy to death from bladder cancer up to 5 years
Overall survival (OS)	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)	5 years
Effect on histopathological stage (Will Rogers phenomenon)	5 years	Definition Effect on histopathologic stage: Influence of extended lymphadenectomy on detection of lymph node metastasis
Influence of adjuvant chemotherapy (by subgroup analysis)	5 years
Documentation of complications	5 years

Trial Locations

Locations (16)

Urological hospital, Städt. Kliniken Dortmund; 🇩🇪 Dortmund, Germany

Department of urology, städt. Klinikum Fulda; 🇩🇪 Fulda, Germany

Heinrich Heine University; 🇩🇪 Düsseldorf, Germany

University of Essen; 🇩🇪 Essen, Germany

Urological Hospital Kassel; 🇩🇪 Kassel, Germany

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

Saarland University; 🇩🇪 Homburg/Saar, Germany

Städt. Klinikum; 🇩🇪 Karlsruhe, Germany

University of Cologne; 🇩🇪 Köln, Germany

Hospital Holweide; 🇩🇪 Köln, Germany

Klinikum r. d. Isar der TUM; 🇩🇪 München, Germany

Otto von Guericke University; 🇩🇪 Magdeburg, Germany

Urological hospital, University Hospital Ulm; 🇩🇪 Ulm, Germany

Paracelsus Hospital; 🇩🇪 Düsseldorf, Germany

Eberhard Karls University; 🇩🇪 Tübingen, Germany

Helios Klinikum Wuppertal; 🇩🇪 Wuppertal, Germany