Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

Bladder Cancer Clinical Trial

Official title:

Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215071
• Other study ID #: AB 25/02
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: January 23, 2018
• Start date: February 2006
• Est. completion date: August 2015

Study information

• Verified date: January 2018
• Source: Association of Urologic Oncology (AUO)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.

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+).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
Germany	Urological hospital, Städt. Kliniken Dortmund	Dortmund
Germany	Heinrich Heine University	Düsseldorf
Germany	Paracelsus Hospital	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	Hospital Holweide	Köln
Germany	University of Cologne	Köln
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

Sponsors (2)

Lead Sponsor	Collaborator
Association of Urologic Oncology (AUO)	Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free Survival (RFS)	Definition Recurrence-free survival: Time from radical cystectomy to tumor reccurence or death from any cause up to 5 years	5 years
Secondary	Cancer specific survival (CSS)	Definition Cancer-specific suvival: Time from radical cystectomy to death from bladder cancer up to 5 years	5 years
Secondary	Overall survival (OS)	Definition Overall survival: Time from radical cystectomy to death from any cause up to 5 years	5 years
Secondary	Determination of type and location of tumour progression(local recurrences and distant metastases)		5 years
Secondary	Effect on histopathological stage (Will Rogers phenomenon)	Definition Effect on histopathologic stage: Influence of extended lymphadenectomy on detection of lymph node metastasis	5 years
Secondary	Influence of adjuvant chemotherapy (by subgroup analysis)		5 years
Secondary	Documentation of complications		5 years

External Links

•   The AUO Homepage where this study is presented