S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Inv… (NCT01224665) | Clinical Trial Compass
CompletedNot Applicable
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer
United States, Canada658 participantsStarted 2011-11-25
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: \*Leve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
5-year Disease-free Survival (DFS)
Timeframe: Duration of treatment and follow-up until death or 6 years after randomization