SIGYN trial - a randomized study comparing gemcitabine and mitomycin in intermediate-risk non-muscle-invasive bladder cancer
| ISRCTN | ISRCTN87250222 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87250222 |
| EudraCT/CTIS number | 2020-001728-33 |
- Submission date
- 23/12/2020
- Registration date
- 10/02/2021
- Last edited
- 24/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
The bladder stores urine before it is passed out of the body. It is located in the front of the pelvis. It is made up of 3 layers – an inner lining, a muscle wall and a thin layer in between called 'connective tissue'. Bladder cancer is a growth of abnormal tissue that starts in the lining and can spread to the muscle wall. Non‑muscle‑invasive bladder cancer (NMIBC) is cancer that has not grown into the muscle wall of the bladder.
A transurethral resection of bladder (TURB) is usually the first treatment for early bladder cancer. The surgeon removes the tumour in the bladder through the urethra. The urethra is the tube that carries urine from the bladder to the outside of the body.
Mitomycin is a chemotherapy drug used to treat different cancers. Gemcitabine is a type of chemotherapy drug.
The aim of this study is to compare the outcomes for gemcitabine compared to mitomycin.
Who can participate?
All individuals with intermediate risk NMIBC operated with radical TURB above the age of 18
What does the study involve?
Participants will be randomly allocated to receive gemcitabine and mitomycin or mitomycin alone weekly for 6 weeks. Participants will be followed up for 24 months.
What are the possible benefits and risks of participating?
Benefits: Potentially better and less toxic treatment for those who receive gemcitabine.
Risks: Chemical cystitis, with the hypothesis that gemcitabine is less toxic than mitomycin.
Where is the study run from?
Eksjö Höglandssjukhuset (Sweden)
When is the study starting and how long is it expected to run for?
June 2020 to December 2026
Who is funding the study?
Cancerfonden (Swedish Cancer Society)
Who is the main contact?
Prof. Fredrik Liedberg, fredrik.liedberg@med.lu.se
Contact information
Scientific
Dept. of Urology
Skåne university Hospital
Jan Waldenströmsgata 5
Malmö
205 02
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46 40 33 19 41 |
| fredrik.liedberg@med.lu.se |
Study information
| Study design | Prospective randomized open study design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Adjuvant instillations in intermediate risk NMIBC: A Study comparIng Gemcitabine and MitomYciN (SIGYN-trial) |
| Study acronym | SIGYN |
| Study hypothesis | In patients with intermediate risk non-muscle invasive bladder cancer treated with serial adjuvant chemotherapy instillations, gemcitabine improves local recurrence free survival compared to mitomycin. |
| Ethics approval(s) | Approved 01/07/2020, Etikprövningsmyndigheten (Swedish Ethical Review Authority, Box 2110, 750 02 Uppsala, Sweden; +46 10 475 08 00; registrator@etikprovning.se), ref: 2020-02143 |
| Condition | Intermediate-risk non-muscle-invasive bladder cancer |
| Intervention | Prospectively randomized study to evaluate local cancer free survival in intermediate risk non-muscle invasive bladder cancer treated with adjuvant gemcitabine compared to current treatment standard which is mitomycin once weekly for six weeks. Participants will be randomised (1:1) using an online tool to: 1. Gemcitabine 100 mg once weekly for 6 weeks 2. Mitomycin 40 mg once weekly for 6 weeks Follow-up of all patients continues until the last patient has been followed for 24 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gemcitabine, mitomycin |
| Primary outcome measure | Local recurrence free survival assessed at cystoscopy controls at 3, 6, 12, 18, 24 months |
| Secondary outcome measures | Measured at baseline and 8 weeks: 1. Treatment related side effects assessed by national questionnaire 2. Health-related quality of life (EORTC-QLQ30+NMIBC24) 3. Health economy progression free survival (EQ-5D-5L) 4. Adverse events (patient records) |
| Overall study start date | 30/06/2020 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 340 |
| Participant inclusion criteria | 1. Aged 18 years or above 2. Intermediate risk non-muscle invasive bladder cancer 3. Radically performed transurethral resection of the tumour 4. Written and verbal consent |
| Participant exclusion criteria | 1. Age below 18 2. Pregnancy 3. Allergy to gemcitabine or mitomycin 4. Chronic catheter 5. Severe incontinence |
| Recruitment start date | 30/06/2021 |
| Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Eksjö
575 33
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology
Jan Waldenströmsgata 7
Malmö
205 02
Sweden
| Phone | +46 (0)40 33 10 00 |
|---|---|
| fredrik.liedberg@med.lu.se | |
| Website | http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality |
Editorial Notes
24/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2025 to 31/12/2026.
2. The overall study end date was changed from 31/12/2025 to 31/12/2026.
3. The intention to publish date was changed from 31/12/2025 to 31/12/2026.
11/12/2023: The recruitment end date was changed from 31/12/2023 to 31/12/2025.
31/12/2020: Trial’s existence confirmed by Etikprövningsmyndigheten (Swedish Ethical Review Authority)
