Overview
Sponsor-declared trial summary
Primary or recurrent non-muscle invasive bladder cancer with intermediate risk of recurrence after transurethral tumour resection
Investigate if adjuvant gemcitabine improves recurrence free survival compared to adjuvant mitomycin
Key facts
- Sponsor
- Region Skane, Region Skane
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Mar 2021 → ongoing
- Decision date (initial)
- 2024-08-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Cancerfonden
External identifiers
- EU CT number
- 2023-504945-30-00
- EudraCT number
- 2020-001728-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Investigate if adjuvant gemcitabine improves recurrence free survival
compared to adjuvant mitomycin
Secondary objectives 1
- Secondary objectives are local side effects and HRQoL two weeks after the last instillation, progression-free survival, health economy and adverse events
Conditions and MedDRA coding
Primary or recurrent non-muscle invasive bladder cancer with intermediate risk of recurrence after transurethral tumour resection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Primary and recurrent non muscle invasive bladder cancer with intermediate risk of recurrence
Exclusion criteria 5
- Age below 18 years of age
- lack of informed consent
- Known allergy to either mitomycin or gemcitabine
- Severe incontinence
- Cronic urethral catheter
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Recurrence-free survival
Secondary endpoints 1
- Local toxicity and HRQol two weeks after last installation, Progression-free survival, Health economy, Adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Gemcitabine Accord 100 mg/ml Koncentrat till infusionsvätska, lösning
PRD1980140 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 45507
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Mitomycin medac, 40 mg, pulver och vätska till intravesikal lösning
PRD3677051 · Product
- Active substance
- Mitomycin
- Substance synonyms
- MITOMYCIN C
- Pharmaceutical form
- INTRAVESICAL SOLUTION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DC03 — MITOMYCIN
- Marketing authorisation
- 50421
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Skane
- Sponsor organisation
- Region Skane
- Address
- Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
- City
- Malmo
- Postcode
- 211 74
- Country
- Sweden
Scientific contact point
- Organisation
- Region Skane
- Contact name
- Fredrik Liedberg
Public contact point
- Organisation
- Region Skane
- Contact name
- Fredrik Liedberg
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Skane Skanes Universitetssjukhus ORG-100011290
|
Lund, Sweden | On site monitoring, Data management |
Region Skane
- Sponsor organisation
- Region Skane
- Address
- Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
- City
- Malmo
- Postcode
- 211 74
- Country
- Sweden
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 340 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2021-03-16 | 2021-04-16 | 2025-08-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504945-30-00 | 1 |
| Protocol (for publication) | D4_EQ-5D-5L_SE | 1 |
| Protocol (for publication) | D4_NMIBC24_SE | 1 |
| Protocol (for publication) | D4_qlq_c30_SE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_SE_2023-504945-30-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mitomycin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE 2023-504945-30-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-20 | Sweden | Acceptable with conditions 2024-08-30
|
2024-08-30 |