Condition category
Cancer
Date applied
01/10/2019
Date assigned
04/11/2019
Last edited
04/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.sahlgrenska.se/en/

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

Editorial Notes

04/11/2019: The participant information sheet has been uploaded as an additional file. 10/10/2019: Trial’s existence confirmed by Swedish Ethical Review Authority