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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00003394 |
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Date of registration:
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20/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective randomized study to comparing an extended pelvic lymphadenectomy with a limited in the surgical treatment of bladder cancer - LEA - AB 25/02
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Scientific title:
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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 |
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Date of first enrolment:
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11/02/2006 |
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Target sample size:
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450 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00003394 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Margitta
Retz |
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Address:
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Ismaninger Str. 22
81675
München
Germany |
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Telephone:
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089 4140-1 |
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Email:
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Margitta.Retz@lrz.tu-muenchen.de |
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Affiliation:
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Klinikum rechts der Isar der TU München |
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Name:
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Margitta
Retz |
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Address:
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Ismaninger Str. 22
81675
München
Germany |
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Telephone:
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089 4140-1 |
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Email:
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Margitta.Retz@lrz.tu-muenchen.de |
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Affiliation:
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Klinikum rechts der Isar der TU München |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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bladder carcinoma
C67
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Malignant neoplasm of bladder
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Intervention(s)
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Group 1: limited lymphadenectomy
Group 2: extended lymphadenectomy
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Primary Outcome(s)
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Progression free Survival [ Time Frame: 5 years ]
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Secondary Outcome(s)
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- 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 ]
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Secondary ID(s)
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NCT01215071
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Source(s) of Monetary Support
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Arbeitsgemeinschaft Urologische Onkologie (AUO) in der Deutschen Krebsgesellschaft e. V.
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Ethics review
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Status: Approved
Approval date: 29/09/2005
Contact:
medizinprodukte@aekno.de
Ethikkommission der Ärztekammer Nordrhein
+49-211-43021581
medizinprodukte@aekno.de
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