Stage 0is Bladder Urothelial CarcinomaNCT02699853
Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer
A study testing Questionnaire Administration and Radical Cystectomy in people with Stage 0is Bladder Urothelial Carcinoma and Stage I Bladder Urothelial Carcinoma, run by University of Southern California at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma
- What is being tested?
- Questionnaire Administration and Radical Cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2016to 16 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Prospective Randomized Comparison of Robotic Versus Open Radical Cystectomy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma
- Being tested
- Questionnaire Administration, Radical Cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Radical CystectomyProcedure or surgery
Also called Complete Cystectomy
Undergo RRC
Radical CystectomyProcedure or surgery
Also called Complete Cystectomy
Undergo ORC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RRC) | Experimental | Patients undergo RRC at day 0. Receives: Other: Questionnaire Administration; Procedure: Radical Cystectomy |
| Arm II (ORC) | Experimental | Patients undergo ORC at day 0. Receives: Other: Questionnaire Administration; Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1-month post cystectomy
Secondary outcomes (1)
Change in erectile dysfunction, as measured by the SHIM score
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start12 Apr 2016
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Why it stopped: PI decided to revamp the protocol completely and will submit as new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 0is Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mihir Desai, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699853
- Sponsor's protocol ID
- 4B-15-4
- Other IDs
- NCI-2016-00080, HS-15-00731, 4B-15-4, P30CA014089
- Status last verified
- May 2019
- First submitted
- 1 Mar 2016
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Robotic Versus Open Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02699853
- Acronym / sponsor ID
- 4B-15-4
- Conditions
- Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decided to revamp the protocol completely and will submit as new study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (RRC) | Experimental | Other: Questionnaire Administration, Procedure: Radical CystectomyPatients undergo RRC at day 0. |
| Arm II (ORC) | Experimental | Other: Questionnaire Administration, Procedure: Radical CystectomyPatients undergo ORC at day 0. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | Arm I (RRC), Arm II (ORC) |
| Radical CystectomyAlso: Complete CystectomyUndergo RRC | Procedure or surgery | Arm I (RRC) |
| Radical CystectomyAlso: Complete CystectomyUndergo ORC | Procedure or surgery | Arm II (ORC) |
Primary outcome
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.
1 secondary outcome
Change in erectile dysfunction, as measured by the SHIM score
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: PI decided to revamp the protocol completely and will submit as new study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihir Desai principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Administration and Radical Cystectomy in people with Stage 0is Bladder Urothelial Carcinoma and Stage I Bladder Urothelial Carcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI decided to revamp the protocol completely and will submit as new study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported quality of life, as measured by the EORTC-QLQ-C30 (time frame: Baseline and 1-month post cystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.