NCT01215071

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

9.5 years

First QC Date

September 29, 2010

Last Update Submit

January 23, 2018

Conditions

Bladder Cancer

Keywords

LymphadenectomyExtensionBladder cancer

Outcome Measures

Primary Outcomes (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

    5 years

Secondary Outcomes (6)

  • Cancer specific survival (CSS)

    5 years

  • Overall survival (OS)

    5 years

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

    5 years

  • Effect on histopathological stage (Will Rogers phenomenon)

    5 years

  • Influence of adjuvant chemotherapy (by subgroup analysis)

    5 years

  • +1 more secondary outcomes

Study Arms (2)

limited lymphadenectomy

EXPERIMENTAL

Fields 5, 7, 9, 11, 13, 14 are removed

Procedure: limited lymphadenectomy

extended lymphadenectomy

EXPERIMENTAL

Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed

Procedure: extended lymphadenectomy

Interventions

limited lymphadenectomyPROCEDURE

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)

Also known as: eingeschränkte Lymphadenektomie, eingeschränkte LA
limited lymphadenectomy
extended lymphadenectomyPROCEDURE

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)

Also known as: ausgedehnte Lymphadenektomie, ausgedehnte LA
extended lymphadenectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Cologne

Cologne, 50937, Germany

Location

Hospital Holweide

Cologne, 51067, Germany

Location

Urological hospital, Städt. Kliniken Dortmund

Dortmund, 44145, Germany

Location

Paracelsus Hospital

Düsseldorf, 40474, Germany

Location

Heinrich Heine University

Düsseldorf, Germany

Location

University of Essen

Essen, 45122, Germany

Location

Department of urology, städt. Klinikum Fulda

Fulda, 36043, Germany

Location

Saarland University

Homburg/Saar, 66421, Germany

Location

Städt. Klinikum

Karlsruhe, 76133, Germany

Location

Urological Hospital Kassel

Kassel, 34125, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Otto von Guericke University

Magdeburg, 39120, Germany

Location

Klinikum r. d. Isar der TUM

München, 81675, Germany

Location

Eberhard Karls University

Tübingen, 72076, Germany

Location

Urological hospital, University Hospital Ulm

Ulm, 89075, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, 42283, Germany

Location

Related Publications (2)

  • 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.

    PMID: 30337060DERIVED

  • 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.

    PMID: 25150172DERIVED

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jürgen E. Gschwend, Prof. Dr.

    AUO - Association of Urologic Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2010

First Posted

October 6, 2010

Study Start

February 1, 2006

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

DE(16)