N/A
Completed N=592
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
Source: ClinicalTrials.gov NCT01224665 ↗Enrolled (actual)
592
Serious AEs
2.5%
Results posted
Nov 2024
Primary outcomePrimary: 5-year Disease-free Survival (DFS) — 60; 56 percentage of participants — p=0.45
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-year Disease-free Survival (DFS) |
60; 56 | 0.45 |
| SECONDARY 5-year Overall Survival (OS) |
63; 59 | — |
| SECONDARY Median Operative Time |
5.3; 5.9 | — |
| SECONDARY Median Days in Hospital |
6; 7 | — |
| SECONDARY Use of Nerve Preservation |
143; 151; 12; 9; 79; 76 | — |
| SECONDARY Lymph Node Counts |
24; 39; 1; 2 | — |
| SECONDARY Receipt of Adjuvant Chemotherapy |
11; 11 | — |
| SECONDARY Frequency of Post-Operative Local Recurrence |
9; 13 | — |
| SECONDARY Post-Operative Morbidity |
1; 8; 7; 19 | — |
Eligibility Criteria
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 irradiation
Data sourced from ClinicalTrials.gov (NCT01224665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.