Overview

This trial is active, not recruiting.

Condition bladder cancer
Treatments limited lymphadenectomy, extended lymphadenectomy
Sponsor Association of Urogenital Oncology (AUO)
Collaborator University of Ulm
Start date March 2006
End date March 2013
Trial size 450 participants
Trial identifier NCT01215071, AB 25/02

Summary

Study is meant to evaluate the influence of different extension of pelvic lymphadenectomy on outcome of patients with bladder cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Fields 5, 7, 9, 11, 13, 14 are removed
limited lymphadenectomy eingeschränkte Lymphadenektomie
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)
(Experimental)
Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
extended lymphadenectomy ausgedehnte Lymphadenektomie
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)

Primary Outcomes

Measure
Progression free Survival
time frame: 5 years

Secondary Outcomes

Measure
Determination of type and location of tumour progression(local recurrences and distant metastases)
time frame: 7 years
disease-specific survival
time frame: 7 years
Influence of adjuvant chemotherapy (by subgroup analysis)
time frame: 7 years
Documentation of complications
time frame: 7 years
Effect on histopathological stage (Will Rogers phenomenon)
time frame: 7 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
Principal investigator Jürgen E. Gschwend, Prof. Dr.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Association of Urogenital Oncology (AUO).