Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

Trial Information

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


The extention of pelvic lymphadenectomy in the surgical treatment of muscle-invasive,
clinically locally bladder cancer is not yet standardized. There are no data from
prospective studies on the prognostic significance 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 his
study patients will be randomized into arms with limited versus extended lymphadenectomy.

The limited lymphadenectomy includes the removal of the obturatorical and external iliac
lymph nodes, the extended one includes the removal of all lymph nodes between pelvic floor
and the departure of the inferior mesenteric artery. The primary objective of the study is
to record the progression-free survival. Secondary study objectives include the creation of
a standard for the surgical treatment and development of quality criteria and implementation
of those into international guidelines. The indication for adjuvant chemotherapy for locally
advanced tumors is not affected.


Inclusion Criteria:



- Histologically, muscle-invasive bladder cancer, locally completely resectable(T2 -
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free Survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Jürgen E. Gschwend, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

AUO Arbeitsgemeinschaft Urologische Onkologie

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AB 25/02

NCT ID:

NCT01215071

Start Date:

March 2006

Completion Date:

March 2013

Related Keywords:

  • Bladder Cancer
  • Lymphadenectomy
  • Extension
  • Bladder cancer
  • Urinary Bladder Neoplasms

Name

Location