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Pelvic Lymphadenectomy for Bladder Cancer

N/A
Waitlist Available
Led By Seth P. Lerner, MD
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage T2, T3, or T4a disease
Histologically confirmed urothelial carcinoma of the bladder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years from date of step 2 registration
Awards & highlights

Study Summary

This trial is comparing two types of surgery for invasive bladder cancer - standard vs extended pelvic lymphadenectomy.

Who is the study for?
This trial is for adults with invasive bladder cancer who are medically fit for cystectomy, have a specific stage of the disease (T2, T3, or T4a), and haven't had certain other cancers recently. They must not be pregnant or nursing and should use contraception if fertile. People can't join if they've had laparoscopic surgery, low-risk stage cancer only, very advanced local disease (T4b), pure squamous cell/adenocarcinoma, metastatic disease above the pelvis, prior partial cystectomy for this cancer or pelvic irradiation.Check my eligibility
What is being tested?
The study compares two types of lymph node removal surgeries in patients with invasive bladder cancer: standard pelvic lymphadenectomy versus extended pelvic lymphadenectomy. It aims to find out which surgery works better when performed during radical cystectomy.See study design
What are the potential side effects?
Potential side effects include complications from surgical procedures such as bleeding, infection risk at the incision site, possible damage to nearby organs or tissues during lymph node removal and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at a stage where it has grown but not spread to distant parts.
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My bladder cancer diagnosis was confirmed through tissue examination.
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My condition needs major bladder surgery and lymph node removal.
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My bladder cancer has various types of cells, including urothelial.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I've completed neoadjuvant chemotherapy for my cancer and have recovered.
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I have no cancer history except for certain skin cancers, early-stage cervical cancer, or any stage I or II cancer from which I've been in remission for 5 years.
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My doctor thinks I am fit for bladder removal surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years from date of step 2 registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years from date of step 2 registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival
Secondary outcome measures
Morbidity
Overall survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment2 Interventions
therapeutic conventional surgery therapeutic extended lymphadenectomy
Group II: Arm IActive Control2 Interventions
therapeutic conventional surgery therapeutic standard lymphadenectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
therapeutic conventional surgery
2003
Completed Phase 3
~12270

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,593 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,952 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,914,988 Total Patients Enrolled

Media Library

Therapeutic Conventional Surgery Clinical Trial Eligibility Overview. Trial Name: NCT01224665 — N/A
Bladder Cancer Research Study Groups: Arm I, Arm II
Bladder Cancer Clinical Trial 2023: Therapeutic Conventional Surgery Highlights & Side Effects. Trial Name: NCT01224665 — N/A
Therapeutic Conventional Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT01224665 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new participants to enter this clinical trial?

"Unfortunately, the clinicaltrials.gov page for this trial conveys that it is not currently recruiting patients. While the trial was first listed on August 1st 2011 and last updated July 20th 2022, 373 other studies are actively enrolling participants at present."

Answered by AI

How many sites are involved in executing this clinical research?

"Patients interested in this clinical trial can receive treatment at UCSF Medical Center-Mission Bay (San Francisco, California), Washington University School of Medicine (Saint Louis, Missouri) and Yale University (New Haven, Connecticut). Additionally there are 35 other sites."

Answered by AI

Does this research permit octogenarian participants?

"To be considered for this investigation, patients must have a chronological age between 18 and 120. There are 10 separate investigations targeting minors while 373 are tailored to elderly applicants."

Answered by AI

Do I meet the requisite qualifications to join this investigation?

"For this clinical trial, 658 patients suffering from urinary bladder cancer, aged 18 to 120 years old, are eligible. To qualify, the following conditions must be met: no prior laparoscopic surgery; disease necessitating a radical cystectomy and lymph node dissection for treatment; stage T2 or higher; absence of low-risk nodal metastasis (carcinoma in situ only); presence of micropapillary or minor components of rare phenotype; and lack of pure squamous cell carcinoma/adenocarcinoma."

Answered by AI
~4 spots leftby May 2024