Clinical trial NCT01215071: Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA
Official title: Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Lymphadenectomy
Extension
Bladder cancer
Lead sponsor: Association of Urologic Oncology (AUO)
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2010-10-06
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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+).

Eligibility 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

Primary outcomes:
measure: Recurrence free Survival (RFS)
timeFrame: 5 years
Secondary outcomes:
measure: Cancer specific survival (CSS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Determination of type and location of tumour progression(local recurrences and distant metastases)
timeFrame: 5 years
measure: Effect on histopathological stage (Will Rogers phenomenon)
timeFrame: 5 years
measure: Influence of adjuvant chemotherapy (by subgroup analysis)
timeFrame: 5 years
measure: Documentation of complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Urological hospital, Städt. Kliniken Dortmund
city: Düsseldorf
country: Germany
facility: Paracelsus Hospital
city: Düsseldorf
country: Germany
facility: Heinrich Heine University
city: Essen
country: Germany
facility: University of Essen
city: Fulda
country: Germany
facility: Department of urology, städt. Klinikum Fulda
city: Homburg/Saar
country: Germany
facility: Saarland University
city: Karlsruhe
country: Germany
facility: Städt. Klinikum
city: Kassel
country: Germany
facility: Urological Hospital Kassel
city: Köln
country: Germany
facility: University of Cologne
city: Köln
country: Germany
facility: Hospital Holweide
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Magdeburg
country: Germany
facility: Otto von Guericke University
city: München
country: Germany
facility: Klinikum r. d. Isar der TUM
city: Tübingen
country: Germany
facility: Eberhard Karls University
city: Ulm
country: Germany
facility: Urological hospital, University Hospital Ulm
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
Study officials:
affiliation: AUO - Association of Urologic Oncology
name: Jürgen E. Gschwend, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.