Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 4:49 PM
Study NCT ID:
NCT01196403
Status:
UNKNOWN
Last Update Posted:
2011-04-01
First Post:
2010-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Sponsor:
Wales Cancer Trials Unit
Organization:
Study Overview
Official Title:
Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer.
PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
Detailed Description:
OBJECTIVES:
Primary
* To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).
Secondary
* To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
* To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
* To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
* To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)
OUTLINE: This is a multicenter study. Patients who consent to the interview-only (but not randomization) undergo a qualitative interview exploring factors relating to this decision. Patients who consent to randomization are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo an open radical cystectomy.
* Arm II: Patients undergo a minimal-access radical cystectomy (laparoscopic or robotic).
Patients complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BLM30) at baseline and at 4 weeks, 6 weeks, 8 weeks, 3 months, and 6 months after completion of study therapy. Blood, urine, and tissue samples are collected from some patients at baseline and during study for laboratory analysis.
After completion of study treatment, patients are followed up at 6 weeks, 3 months, and 6 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 92 patients (72 patients for the randomized portion and 20 for the interview-only portion) are accrued for this study.
Primary
* To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).
Secondary
* To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
* To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
* To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
* To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)
OUTLINE: This is a multicenter study. Patients who consent to the interview-only (but not randomization) undergo a qualitative interview exploring factors relating to this decision. Patients who consent to randomization are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo an open radical cystectomy.
* Arm II: Patients undergo a minimal-access radical cystectomy (laparoscopic or robotic).
Patients complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BLM30) at baseline and at 4 weeks, 6 weeks, 8 weeks, 3 months, and 6 months after completion of study therapy. Blood, urine, and tissue samples are collected from some patients at baseline and during study for laboratory analysis.
After completion of study treatment, patients are followed up at 6 weeks, 3 months, and 6 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 92 patients (72 patients for the randomized portion and 20 for the interview-only portion) are accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: