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BRIEF TITLE: Prospective Randomized Comparison of Robotic Versus Open Radical Cystectomy

Prospective Randomized Comparison of Robotic Versus Open Radical Cystectomy


  • Org Study ID: 4B-15-4
  • Secondary ID: NCI-2016-00080,HS-15-00731,4B-15-4,P30CA014089
  • NCT ID: NCT02699853
  • NCT Alias:
  • Sponsor: University of Southern California - Other
  • Source: University of Southern California

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.

Detailed Description


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.

Overal Status Start Date Phase Study Type
Recruiting April 12, 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Change in patient reported quality of life, as measured by the EORTC-QLQ-C30

Primary Outcome 1 - Time Frame: Baseline and 1-month post cystectomy

Condition:

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

Eligibility

Criteria:
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
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Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Mihir Desai

Role: Principal Investigator

Affiliation: University of Southern California

Overall Contact

Name: Ileana Aldana

Phone: 323-865-0702

Email: Ileana.aldana@med.usc.edu

Location

Facility Status Contact
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Mihir Desai, MD
323-865-3700
Mihir.Desai@med.usc.edu