Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer
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ClinicalTrials.gov Identifier: NCT02699853 |
Recruitment Status :
Terminated
(PI decided to revamp the protocol completely and will submit as new study.)
First Posted : March 4, 2016
Last Update Posted : May 3, 2019
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Condition or disease | Intervention/treatment | Phase |
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Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma | Other: Questionnaire Administration Procedure: Radical Cystectomy | Not Applicable |
PRIMARY OBJECTIVES:
I. To compare RRC to ORC in terms of the difference in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core (QLQC)30 quality of life instrument assessed at baseline to day 30 after radical cystectomy (RC).
II. To compare RRC to ORC in terms of the 90-day high-grade complication rate (where high grade is defined as Clavien-Dindo grade 3-5).
III. To compare the peri-operative cost of the RC procedure, as defined as from the day of hospital admission to the day of hospital discharge.
SECONDARY OBJECTIVES:
I. To estimate the differences between RRC and ORC in terms of the following quality of life outcomes: Narcotic requirements prior to RC, during hospital stay and on days 7, 14, 30, 6 weeks, and 3, 6, 9 and 12 months; Visual Analog Scale (VAS) pain score prior to RC and on days 7, 14, 30, 6 weeks, and 3, 6, 9 and 12 months; the EORTC-QLQ-30 prior to RC and at 3, 6, 9, and 12 months; the bladder cancer index (BCI) at 30 days and 3, 6, 9, and 12 months; the Sexual Health Inventory for Men (SHIM) prior to RC and at 3, 6, 9, and 12 months; the World Health Organization (WHO) Quality of Life (QOL) questionnaire prior to RC and at 30 days and 3, 6, 9, and 12 months.
II. To estimate the differences between RRC and ORC in terms of the following surgical and complication outcomes: all complications occurring intraoperatively, during postoperative hospitalization and during the 90 days post cystectomy assessed at 7, 14, and 30 days; at 6 weeks and at 3 months-graded according to the Clavien-Dindo classification; all complications, all grade 3+ complications, and all grade 4+ complications; time to oral intake; estimated blood loss during surgery, number of transfusions on the day of surgery; drop in hematocrit at 24 hours; lymph node yield; and positive surgical margin.
III. To estimate the differences between RRC and ORC in terms of the following cost-related outcomes: operation room time; number of disposables used; pharmacy costs; length of hospital stay; admission to intensive care unit (ICU) prior to discharge & length of stay in ICU; number of hospital readmissions within 30 and 90 days (3 months); necessary tests/procedures to treat complications during hospitalization and within 30 and 90 days.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo RRC at day 0.
ARM II: Patients undergo ORC at day 0.
After completion of study treatment, patients are followed up at 7 days, 30 days, 6 weeks, and at 3, 6, 9, and 12 months.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Prospective Randomized Comparison of Robotic Versus Open Radical Cystectomy |
Actual Study Start Date : | April 12, 2016 |
Actual Primary Completion Date : | November 16, 2018 |
Actual Study Completion Date : | November 16, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I (RRC)
Patients undergo RRC at day 0.
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Other: Questionnaire Administration
Ancillary studies Procedure: Radical Cystectomy Undergo RRC
Other Name: Complete Cystectomy |
Experimental: Arm II (ORC)
Patients undergo ORC at day 0.
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Other: Questionnaire Administration
Ancillary studies Procedure: Radical Cystectomy Undergo ORC
Other Name: Complete Cystectomy |
- Change in patient reported quality of life, as measured by the EORTC-QLQ-C30 [ Time Frame: Baseline and 1-month post cystectomy ]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.
- Change in erectile dysfunction, as measured by the SHIM score [ Time Frame: up to 12 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699853
United States, California | |
USC / Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Mihir Desai | University of Southern California |
Responsible Party: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT02699853 |
Other Study ID Numbers: |
4B-15-4 NCI-2016-00080 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) HS-15-00731 4B-15-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
First Posted: | March 4, 2016 Key Record Dates |
Last Update Posted: | May 3, 2019 |
Last Verified: | May 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Transitional Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |