Treatment of bladder cancer with gemcitabine and docetaxel (for people not responding to Bacillus Calmette-Guerin (BCG) treatment)
| ISRCTN | ISRCTN17499170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17499170 |
- Submission date
- 30/01/2023
- Registration date
- 15/02/2023
- Last edited
- 09/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Bladder cancer is a type of cancer that starts in the bladder, a muscular organ in the lower abdomen that stores urine.
Bacillus Calmette-Guerin (BCG) treatment is a type of immunotherapy used to treat bladder cancer by boosting the body's natural defence system. It is instilled directly into the bladder to fight the cancer cells.
When people with bladder cancer do not respond to or cannot tolerate BCG treatment, and cannot have a radical cystectomy due to health problems or their own decision, there are no proven treatment options. Doctors recommend these patients take part in clinical trials. A type of treatment using gemcitabine and docetaxel has been reported to have good results with limited side effects in some studies, but it has not been tested in a large, controlled trial. This study will examine the effectiveness and side effects of the gemcitabine and docetabine treatment, as well as its cost and whether the type of bladder cancer cells predicts how well the treatment works.
Who can participate?
Patients with non-BCG-responsive bladder cancer not suitable for surgery to remove the bladder.
What does the study involve?
Patients are treated with gemcitabine and docetaxel including six weekly induction courses and maintenance installations once a month for nine months. Follow-up is for 24 months.
What are the possible benefits and risks of participating?
Patients participating will receive a second-line treatment that seems very promising. The same risks as for all intravesical treatments with chemical cystitis are the main side-effects that are anticipated.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2023 to March 2029
Who is funding the study?
Skåne University Hospital (Sweden)
Who is the main contact?
Prof Fredrik Liedberg, fredrik.liedberg@med.lu.se
Contact information
Principal Investigator
Skåne University Hospital
Department of Urology
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46 40 33 10 00 |
| fredrik.liedberg@med.lu.se |
Study information
| Study design | Prospective interventional single-arm phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43136 PIS.pdf |
| Scientific title | Sequential instillations with gEmCitaBin and dOcetaxel for BCG-unrespoNsive and BCG-intolerant blaDdercancer – SECOND-trial. |
| Study acronym | SECOND-trial |
| Study hypothesis | Sequential instillations with gem/doc for BCG-unresponsive Non-muscle-invasive Bladder Cancer (NMIBC) can be administered with reasonable toxicity and recurrence-free survival in patients not suitable for radical cystectomy. |
| Ethics approval(s) | Approved 29/01/2023, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: EPM 2022-06399-01. |
| Condition | Non-muscle-invasive bladder cancer |
| Intervention | The prospective trial investigates intravesical administration of sequential gemcitabine and docetaxel (gem/doc) including six weekly induction courses and maintenance installations once a month for 9 months to assess RFS and complete response at 12 and 24 months, as well as side effects, health-related quality of life and health economic evaluation. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gemcitabine, docetaxel |
| Primary outcome measure | 1. Complete remission (CR) at 24 months measured using patient records 2. Recurrence-Free Survival (RFS) and Progression-Free Survival (PFS) assessed by cystoscopies and voided urinary cytology during follow-up. |
| Secondary outcome measures | 1. Health-related quality of life is assessed by EORTC-QLQ30-NMIBC24 before induction treatment, four weeks after induction chemotherapy at 10 weeks and four weeks after completion of all 9 maintenance installations. 2. Side-effects are monitored before each installation by the national side-effect questionnaire. 3. Health economic assessment is performed by applying data from the EQ-5D-5L and EORTC-QLQ30-NMIBC24 questionnaires at the end of the study |
| Overall study start date | 29/01/2023 |
| Overall study end date | 01/03/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. BCG-unresponsive NMIBC 2. BCG-intolerant NMIBC 3. BCG-recurrent NMIBC |
| Participant exclusion criteria | 1. Allergy to either gem or doc 2. Chronic urinary catheter 3. Severe incontinence affecting possibilities to retain intravesical instillations |
| Recruitment start date | 01/03/2023 |
| Recruitment end date | 01/03/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Jan Waldenströmsgata 5
Malmö
205 02
Sweden
Landskrona
SE-261 36
Sweden
Helsingborg
SE-252 23
Sweden
Ängelholm
SE-262 52
Sweden
Växjö
SE-352 34
Sweden
Ljungby
SE-341 35
Sweden
Eksjö
SE-575 81
Sweden
Jönköping
SE-553 05
Sweden
Värnamo
SE-331 52
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology
Jan Waldenströmsgata 5
Malmö
SE-20502
Sweden
| Phone | +46 40 33 10 00 |
|---|---|
| jenny.hellfalk@skane.se | |
| Website | http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Skåne University Hospital, SUS
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/03/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer-reviewed medical journal |
| IPD sharing plan | Available on request. fredrik.liedberg@med.lu.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 31/01/2023 | No | Yes |
Additional files
Editorial Notes
09/06/2025: The contact confirmed the record is up to date.
01/05/2024: Study record is up to date.
04/04/2023: Internal review.
31/01/2023: Trial's existence confirmed by Swedish Ethical Review Authority.
