Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer

NCT02699853 | Terminated DMC

• 4 other identifiers: 4B-15-4NCI-2016-00080HS-15-00731P30CA014089
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a surgical procedure to remove all or part of the bladder (the organ that holds urine) or to remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in the abdomen and uses a thin, lighted instrument with a camera attached called a scope. With the help of a robot, the surgeon removes the bladder and other nearby structures. In ORC, the surgeon makes a cut into the lower abdomen to expose the urinary tract in order to remove the bladder and nearby structures. It is not yet known whether RRC or ORC has fewer complications, better quality of life, and faster recovery time in treating patients with bladder cancer.

Conditions

Stage 0is Bladder Urothelial Carcinoma; Stage I Bladder Urothelial Carcinoma; Stage II Bladder Urothelial Carcinoma; Stage III Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in patient reported quality of life, as measured by the EORTC-QLQ-C30

  The results for the two arms will be summarized using graphical methods and standard descriptive statistics. Means (or medians) and associated 95% confidence intervals-for each arm separately and for the difference-will be used to display the patterns. For QoL variables that are assessed at multiple times post cystectomy, regression methods that accommodate repeated measures will be used to assess patterns over time. Analyses will compare the two arms using general linear regression models and stratifying for the four variables used for stratification prior to randomization.

  Baseline and 1-month post cystectomy

Secondary Outcomes (1)

• Change in erectile dysfunction, as measured by the SHIM score

  up to 12 months

Study Arms (2)

Arm I (RRC)

EXPERIMENTAL

Patients undergo RRC at day 0.

Other: Questionnaire Administration; Procedure: Radical Cystectomy

Arm II (ORC)

EXPERIMENTAL

Patients undergo ORC at day 0.

Other: Questionnaire Administration; Procedure: Radical Cystectomy

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (RRC); Arm II (ORC)

Radical Cystectomy PROCEDURE

Undergo RRC

Also known as: Complete Cystectomy

Arm I (RRC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for radical cystectomy for urothelial cancer
• All types of urinary diversions
• Tis-T3 Urothelial cancer; patients will be stratified according to clinical stage
• Ability to consent
• Patient meets criteria to be a surgical candidate

You may not qualify if:

• Inability to give consent or adhere to follow-up schedule
• T4 tumor
• Bulky lymphadenopathy (\> 2 cm)
• Prior pelvic radiation
• Not surgical candidate because of significant co-morbidity
• Uncontrolled coagulopathy

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Cystectomy

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mihir Desai

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 4, 2016
• Study Start: April 12, 2016
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

US (1)