Plain English Summary
Background and study aims
Bladder cancer is one of the most common forms of cancer. For most patients, the bladder cancer is superficial and can be treated locally in the bladder. However, for about one in five patients, cancer invades the bladder muscle and for these the most common curative treatment is cystectomy. Cystectomy can be performed either as open surgery, with a longer incision in the lower abdomen, or as a robot-assisted laparoscopic procedure. Robot-assisted laparoscopic cystectomy has been developed during the last 15 years and is routinely performed at some centres around the world. However, it is not entirely certain that a laparoscopic cystectomy is as safe as open surgery, or that there are sufficient advantages to offset the higher procedure-related costs. The aim of this study is, therefore, to find out whether robot-assisted laparoscopic cystectomy is oncologically as safe as open cystectomy, whether there is a difference in rates of complications, and if it is cost-effective
Who can participate?
Men and women with urinary bladder cancer planned to undergo cystectomy
What does the study involve?
Participants are randomly allocated to either robot-assisted laparoscopic cystectomy (experimental group) or open cystectomy (control group)
What are the possible benefits and risks of participating?
Robot-assisted laparoscopic cystectomy may lead to less blood loss, faster recovery, and fewer complications than open cystectomy. It is possible, however, that there may be an increased risk of recurrence or progression from bladder cancer
Where is the study run from?
University of Gothenburg/Sahlgrenska University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
September 2019 to 2024
Who is funding the study?
The study is funded by the Agreement concerning research and education of doctors in Sweden
Who is the main contact?
Dr Henrik Kjölhede
henrik.kjolhede@vgregion.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Henrik Kjölhede
ORCID ID
http://orcid.org/0000-0001-6441-4729
Contact details
Department of Urology
Institute of Clinical Sciences
University of Gothenburg
Bruna stråket 11B
Sahlgrenska University Hospital
Gothenburg
413 45
Sweden
+46 31 342 10 00
henrik.kjolhede@vgregion.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2019-00717 / 844-18
Study information
Scientific title
Robotic-Assisted radical Cystectomy vErsus open Radical cystectomy: a randomised non-inferiority trial comparing 3-year recurrence-free survival in patients undergoing cystectomy for urothelial carcinoma of the bladder
Acronym
RACER
Study hypothesis
Robot assisted laparoscopic cystectomy is non-inferior to open cystectomy with regards to 3-year progression-free survival
Ethics approval
Approved 07/01/2019, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; +46-10-4750800), ref: 2019-00717 / 844-18
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional file (in Swedish)
Condition
Bladder cancer
Intervention
For both the treatment arms, eligible patients will be offered neo-adjuvant or induction chemotherapy. Randomisation to robot assisted or open surgery will be performed after any preoperative chemotherapy has been finished. Randomisation will be performed through an electronic data capture system, with a computer-generated list. Treatment arms will be stratified by participating centre and muscle-invasive or non-muscle-invasive disease. Both arms will undergo surgery with an identical enhanced recovery protocol.
Participating subjects will receive either robot assisted laparoscopic cystectomy (experimental arm) or open cystectomy (control arm). The urinary deviation can be performed either entirely intra-corporeally or through a small incision extra-corporeally. The type of deviation is at the discretion of the surgeon and patient. All surgeons participating in the study is mandated to have performed at least 10 cystectomies of the relevant type (open or robotic) in the preceding year.
Follow-up will be performed with CT thorax and abdomen, which will be assessed by RECIST criteria, according to the Swedish National Guidelines for urothelial cancer. This follow-up scheme is dependent on the final pathology report, and may be subject to change according to updates in the National Guidelines.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Progression-free survival at three years following cystectomy
Secondary outcome measures
Surgical outcomes:
1. Rate of complications
2. Blood loss
3. Rate of transfusion
4. Time of stay
Long-term outcomes:
5. Rate of unplanned readmission
6. Quality of life measured by questionnaires FACT-G/Bl-Cys and WHODAS2.0 at baseline, and 3, 6 and 12 months and EQ-5D-5L at baseline and weekly for the first 4 postoperative weeks
7. Total health-care related costs following cystectomy, calculated for the direct and indirect costs related to the surgery for the first 6 months
Overall trial start date
01/09/2019
Overall trial end date
01/09/2027
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically verified urothelial cancer
2. cT1-4a or BCG-unresponsive CIS
3. N0-1, or N2-3 if response on pre-operative chemotherapy to N0-1
4. Able to sign informed consent
Participant type
All
Age group
Adult
Gender
Both
Target number of participants
488
Participant exclusion criteria
1. Distant metastasis (M1)
2. Unfit for either type of procedure
3. Extant ileo- or colostomy
4. Duplicated ureters
Recruitment start date
04/11/2019
Recruitment end date
31/12/2024
Locations
Countries of recruitment
Sweden
Trial participating centre
University of Gothenburg/Sahlgrenska University Hospital
Department of Urology
Bruna Stråket 11B
Gothenburg
413 45
Sweden
Trial participating centre
University of Lund/Skåne University Hospital
Department of Urology
Jan Waldenströms Gata 5
Malmö
214 28
Sweden
Sponsor information
Organisation
Sahlgrenska University Hospital
Sponsor details
413 45 Gothenburg
Gothenburg
413 45
Sweden
+46 31 342 10 00
sahlgrenska.universitetssjukhuset@vgregion.se
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The study is funded by the Agreement concerning research and education of doctors in Sweden.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as ethical approval does not allow it.
Intention to publish date
01/06/2026
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN64538003_PIS_10Oct19.pdf uploaded 04/11/2019