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Clinical Trials/DRKS00003394
DRKS00003394
Completed
未知

Prospective randomized study to comparing an extended pelvic lymphadenectomy with a limited in the surgical treatment of bladder cancer - LEA - AB 25/02 - LEA - AB 25/02

Klinikum rechts der Isar der TU München0 sites459 target enrollmentJanuary 20, 2012

Overview

Phase
未知
Intervention
Not specified
Conditions
bladder carcinoma
Sponsor
Klinikum rechts der Isar der TU München
Enrollment
459
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 20, 2012
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinikum rechts der Isar der TU München

Eligibility Criteria

Inclusion Criteria

  • Histologically, muscle\-invasive bladder cancer, locally completely resectable(T2 \- T4a, Nx)
  • \- 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

Outcomes

Primary Outcomes

Not specified

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