Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

Association of Urologic Oncology (AUO)

Status

Completed

Conditions

Bladder Cancer

Treatments

Procedure: limited lymphadenectomy

Procedure: extended lymphadenectomy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01215071

AB 25/02

Details and patient eligibility

About

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

Full 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+).

Enrollment

401 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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