therapeutic extended lymphadenectomy for Urinary Bladder Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford Cancer Institute, Palo Alto, CA
Urinary Bladder Cancer+1 More
therapeutic extended lymphadenectomy - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether extended pelvic lymphadenectomy is more effective than standard pelvic lymphadenectomy in treating patients with invasive bladder cancer.

See full description

Eligible Conditions

  • Urinary Bladder Cancer
  • Bladder Cancer, Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether therapeutic extended lymphadenectomy will improve 1 primary outcome and 2 secondary outcomes in patients with Urinary Bladder Cancer. Measurement will happen over the course of Up to 6 years from date of Step 2 Registration.

Year 6
Disease-free survival
Morbidity
Overall survival

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Arm I
1 of 2
Arm II
1 of 2
Active Control
Experimental Treatment

This trial requires 658 total participants across 2 different treatment groups

This trial involves 2 different treatments. Therapeutic Extended Lymphadenectomy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm IItherapeutic conventional surgery therapeutic extended lymphadenectomy
Arm Itherapeutic 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
~11930

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 years from date of step 2 registration
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 years from date of step 2 registration for reporting.

Closest Location

Stanford Cancer Institute - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
has ever been reported No cases of T4b disease (fixed lesion) have ever been reported. show original
No laparoscopic surgery
A disease that requires the surgical removal of the bladder, prostate, and surrounding lymph nodes in order to cure it. show original
Squamous cell carcinoma
is the most common malignancy of the urinary tract show original
Stage T2, T3, or T4a disease
The patient has a low-risk of node metastasis, meaning they only have cancer in the cells in the original tumor (CIS only) and have not spread to the lymph nodes. show original
Adenocarcinoma
Minor components of other rare phenotypes. show original
No pure squamous cell carcinoma or adenocarcinoma

Patient Q&A Section

What causes urinary bladder cancer?

"The risk factors and underlying mechanisms for bladder cancer are complex and multifactorial, resulting from the interconnection of environmental exposures, genetic susceptibility, and the epigenetic profile at the cellular level. Further studies are warranted." - Anonymous Online Contributor

Unverified Answer

How many people get urinary bladder cancer a year in the United States?

"This article describes the incidence of urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) in the United States. The data show the incidence of urinary bladder cancer to be 0.4 percent of all new cancer cases in the USA every year. The 5-year survival rate of urinary bladder cancer is 75.3%. The incidence of urinary bladder cancer per 1,000,000 was 7.8. Urinary bladder cancer has the highest mortality of any type of cancer in the United States. The overall 5-year survival rate for urinary bladder cancer is 27.4%. A study done in Japan found that the incidence rate of urinary bladder cancer per million people per year is 7.7. The 5-year survival rate in Japan is 74.3%." - Anonymous Online Contributor

Unverified Answer

What are common treatments for urinary bladder cancer?

"There are significant number of alternative therapies that are used to treat bladder cancer. However, the best of the alternative therapies has not been proven to be effective." - Anonymous Online Contributor

Unverified Answer

What is urinary bladder cancer?

"The urinary bladder is the first part of the urinary tract affected by cancer in children and adolescents. The most common type of urinary bladder cancer is transitional cell carcinoma, a malignancy of bladder cells. A number of factors are involved in the development and progression of bladder cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of urinary bladder cancer?

"The most frequent symptom of bladder cancer is hematuria (blood in the urine), followed by urgency, incontinence and dysuria. There is also a correlation between these symptoms and bladder mass. The symptom of hematochezia (blood in stool), often seen in other gastrointestinal diseases can also be a symptom of bladder cancer. However, it is not an indispensable sign." - Anonymous Online Contributor

Unverified Answer

Can urinary bladder cancer be cured?

"Urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) cannot be cured. Despite a considerable number of advanced cancer patients having undergone treatment, over half of those patients will have a local recurrence at a median of 3 and 6 years, respectively. Although the best possible treatment cannot be guaranteed, the current data indicate that some patients can live normal lives for years following treatment." - Anonymous Online Contributor

Unverified Answer

What does therapeutic extended lymphadenectomy usually treat?

"Extended lymphadenectomy has long been assumed to have a therapeutic role in localized patients with T3 urothelial carcinoma of the urinary bladder; this assumption has not been validated by good-quality data." - Anonymous Online Contributor

Unverified Answer

How does therapeutic extended lymphadenectomy work?

"We have established that complete lymphadenectomy is feasible on a large percentage of patients having radical cystectomy. This will help improving survival of [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) patients, as complete removal of the lymphatic region that carries the metastatic cancers increases the efficacy of the cytotoxic therapy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for urinary bladder cancer?

"Urinary bladder cancer treatment is still largely based on its TNM staging, and there have been no new studies and interventions since 2005. Although there has been more research over time, bladder cancer remains unchanged as a devastating disease. More effort needs to be put into increasing bladder cancer screening, and developing innovative treatment options." - Anonymous Online Contributor

Unverified Answer

Is therapeutic extended lymphadenectomy typically used in combination with any other treatments?

"Lymphadenectomy +/- chemotherapy +/- hIL-2 +/- autologous stem cell transplantation may be used in patients with stage IIIB renal cell carcinoma. Patients with T3 bladder cancer should also undergo radical cystectomy +/- hIL-2 +/- autologous stem cell transplantation." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of therapeutic extended lymphadenectomy?

"To our knowledge, this is the first comprehensive study in the literature to compare the treatment result of therapeutic extended lymphadenectomy with those of conventional and modified lymphadenectomy in patients with bladder cancer. No statistically significant difference in PFS and OS were observed between treatment groups; however, more patients experienced an increased incidence of postoperative infection, thromboembolism, urinary incontinence, and urinary retention. A larger study is warranted to further investigate this finding." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing urinary bladder cancer?

"Urinary bladder cancer is found in only five to ten persons in every 1 million. Most bladder cancers are non-muscle-invasive and can be detected in the early stages. The probability of developing bladder cancer is about one in twenty for men and one in sixty for women at 85 years of age." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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