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AzTrials

Bladder CancerNCT01215071

Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

A study testing limited lymphadenectomy and extended lymphadenectomy in people with Bladder Cancer, run by Association of Urologic Oncology (AUO) at 16 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
limited lymphadenectomy and extended lymphadenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
401 participants
Where
16 sitesGermany
Study dates
Feb 2006to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • University of Cologne

    Cologne, 50937

  • Hospital Holweide

    Cologne, 51067

  • Urological hospital, Städt. Kliniken Dortmund

    Dortmund, 44145

  • Paracelsus Hospital

    Düsseldorf, 40474

  • Heinrich Heine University

    Düsseldorf

  • University of Essen

    Essen, 45122

  • Department of urology, städt. Klinikum Fulda

    Fulda, 36043

  • Saarland University

    Homburg/Saar, 66421

  • Städt. Klinikum

    Karlsruhe, 76133

  • Urological Hospital Kassel

    Kassel, 34125

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Otto von Guericke University

    Magdeburg, 39120

  • Klinikum r. d. Isar der TUM

    München, 81675

  • Eberhard Karls University

    Tübingen, 72076

  • Urological hospital, University Hospital Ulm

    Ulm, 89075

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

About this study

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

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

Read the detailed 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+).

Conditions
Bladder Cancer
Being tested
limited lymphadenectomy, extended lymphadenectomy
Keywords
Lymphadenectomy, Extension, Bladder cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • limited lymphadenectomyProcedure or surgery

    Also called eingeschränkte Lymphadenektomie, eingeschränkte LA

    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)

  • extended lymphadenectomyProcedure or surgery

    Also called ausgedehnte Lymphadenektomie, ausgedehnte LA

    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)

Study groups in NCT01215071
Study groupRoleWhat they receive
limited lymphadenectomyExperimentalFields 5, 7, 9, 11, 13, 14 are removed
Receives: Procedure: limited lymphadenectomy
extended lymphadenectomyExperimentalFields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
Receives: Procedure: extended lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence free Survival (RFS)

    Definition Recurrence-free survival: Time from radical cystectomy to tumor reccurence or death from any cause up to 5 years

    Measured: 5 years

Secondary outcomes (6)

  1. Cancer specific survival (CSS)

    Definition Cancer-specific suvival: Time from radical cystectomy to death from bladder cancer up to 5 years

    Measured: 5 years

  2. Overall survival (OS)

    Definition Overall survival: Time from radical cystectomy to death from any cause up to 5 years

    Measured: 5 years

  3. Determination of type and location of tumour progression(local recurrences and distant metastases)

    Measured: 5 years

  4. Effect on histopathological stage (Will Rogers phenomenon)

    Definition Effect on histopathologic stage: Influence of extended lymphadenectomy on detection of lymph node metastasis

    Measured: 5 years

  5. Influence of adjuvant chemotherapy (by subgroup analysis)

    Measured: 5 years

  6. Documentation of complications

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2010 (estimated)
  2. Study startFeb 2006
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01215071
Sponsor's protocol ID
AB 25/02
Status last verified
Jan 2018
First submitted
29 Sep 2010
Last updated
24 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gschwend JE, Heck MM, Lehmann J, Rubben H, Albers P, Wolff JM, Frohneberg D, de Geeter P, Heidenreich A, Kalble T, Stockle M, Schnoller T, Stenzl A, Muller M, Truss M, Roth S, Liehr UB, Leissner J, Bregenzer T, Retz M. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol. 2019 Apr;75(4):604-611. doi: 10.1016/j.eururo.2018.09.047. Epub 2018 Oct 15.

    PubMed 30337060

  • Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hubler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19.

    PubMed 25150172

Questions about this trial

What is this clinical trial studying?

A study testing limited lymphadenectomy and extended lymphadenectomy in people with Bladder Cancer, run by Association of Urologic Oncology (AUO) at 16 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free Survival (RFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01215071, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.

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