Clinical trial · Interventional
Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA
Prospektiv Randomisierte Studie Zum Vergleich Einer Ausgedehnten Mit Einer eingeschränkten Pelvinen Lymphadenektomie Bei Der Operativen Therapie Des Harnblasenkarzinoms
NCT01215071CI-TRIAL-00031348completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| extended lymphadenectomy | Procedure | — | UNRESOLVED |
| limited lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- limited lymphadenectomy
- description
- Fields 5, 7, 9, 11, 13, 14 are removed
- interventionNames
- Procedure: limited lymphadenectomy
- type
- EXPERIMENTAL
- label
- extended lymphadenectomy
- description
- Fields 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 are removed
- interventionNames
- Procedure: extended lymphadenectomy
Primary outcomes (1)
- measure
- Recurrence free Survival (RFS)
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (2)
- DERIVEDGschwend 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 30337060
- DERIVEDFroehner 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 25150172