Clinical trial · Interventional
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer
NCT01224665CI-TRIAL-00083128completedN/AResults postedClinicalTrials.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)
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in patients with invasive bladder cancer. It is not yet known whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery. PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| therapeutic extended lymphadenectomy | Procedure | — | UNRESOLVED |
| therapeutic standard lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- therapeutic conventional surgery therapeutic standard lymphadenectomy
- interventionNames
- Procedure: therapeutic conventional surgery
- Procedure: therapeutic standard lymphadenectomy
- type
- EXPERIMENTAL
- label
- Arm II
- description
- therapeutic conventional surgery therapeutic extended lymphadenectomy
- interventionNames
- Procedure: therapeutic conventional surgery
- Procedure: therapeutic extended lymphadenectomy
Primary outcomes (1)
- measure
- 5-year Disease-free Survival (DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed urothelial carcinoma of the bladder
* Stage T2, T3, or T4a disease
* No clinical stage consistent with a low-risk of node metastasis (CIS only, T1)
* No T4b disease (fixed lesion)
* Disease that requires primary radical cystectomy and lymph node dissection for definitive treatment
* No laparoscopic surgery
* Predominant urothelial carcinoma with any of the following elements allowed:
* Adenocarcinoma
* Squamous cell carcinoma
* Micropapillary or minor components of other rare phenotype
* No pure squamous cell carcinoma or adenocarcinoma
* No visceral or nodal metastatic disease proximal to the common iliac bifurcation by 2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of the abdomen and pelvis
* No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or above the bifurcation of the common iliac vessels in any of the extended template
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* ALT and AST ≤ upper limit of normal (ULN)\*
* Alkaline phosphatase ≤ ULN\*
* Not pregnant or nursing
* Fertile patients must use an effective contraception
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in complete remission for the past 5 years
* Medically suitable to undergo cystectomy, in the physician's opinion NOTE: \*Levels may be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone scan, or biopsy.
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior partial cystectomy for invasive bladder cancer
* No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g., aorto-femoral/iliac bypass)
* Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed and patient has recovered
* No prior pelvic irradiationReferences
Publications (3)
- DERIVEDLerner SP, Tangen C, Svatek RS, Daneshmand S, Pohar KS, Skinner E, Schuckman A, Sagalowsky AI, Smith ND, Kamat AM, Kassouf W, Plets M, Bangs R, Koppie TM, Alva A, La Rosa FG, Pal SK, Kibel AS, Canter DJ, Thompson IM Jr; SWOG S1011 Trial Investigators. Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer. N Engl J Med. 2024 Oct 3;391(13):1206-1216. doi: 10.1056/NEJMoa2401497. PMID 39589370
- DERIVEDKamat AM, Hahn NM, Efstathiou JA, Lerner SP, Malmstrom PU, Choi W, Guo CC, Lotan Y, Kassouf W. Bladder cancer. Lancet. 2016 Dec 3;388(10061):2796-2810. doi: 10.1016/S0140-6736(16)30512-8. Epub 2016 Jun 23. PMID 27345655
- 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