Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruiting
Participants planned
312
Countries
1
Sites
4
Non-muscle invasive bladder cancer
Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.
Key facts
- Sponsor
- Hospital Universitario La Paz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 May 2018 → ongoing
- Decision date (initial)
- 2024-04-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512683-53-00
- EudraCT number
- 2017-004070-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.
Secondary objectives 5
- Evaluation of toxicity, adverse events and complications attributable to intravesical instillation of chemotherapy prior to TURBT.
- To determine the rate of late recurrences (between 12 and 60 months after the intervention) in both groups.
- To compare the recurrence-free time between the two groups.
- To determine clinical and demographic variables that could influence a better clinical response. 5. To determine if there are differences in the rate of recurrences, adverse effects and other variables between patients in the intervention group who have received different drugs.
- To determine whether there are differences in recurrence rates, adverse effects and other variables between patients in the intervention group who have received different drugs.
Conditions and MedDRA coding
Non-muscle invasive bladder cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Clinical trial Phase IV, randomised, open-label Clinical trial Phase IV, randomised, open-label.
|
Randomised Controlled | None | Experimental arm: Intravesical chemotherapy instillation + transurethral resection group: Under regional or general anaesthesia, 1 instillation of Mitomycin C will be performed through a bladder catheter. The dose received will be 40 mg diluted in 40 mL of physiological saline. This is the recommended and authorised dose of this drug. In case of Mitomycin C shortage, the following drugs will be used at their recommended concentrations and doses for this disease (Epirubicin 50 mg in 50 cc of physiological saline solution; Gemcitabine 1g dissolved in 50 cc of physiological saline solution; Adriamycin 50 mg in 50 cc of physiological saline solution; Cisplatin 30 mg dissolved in 50 cc of physiological saline solution; Docetaxel 40 mg dissolved in 40 cc of sterile water). The drug is kept in the bladder for 15 minutes, after which the bladder is emptied and the bladder catheter is removed. This is followed by the planned bladder exploration and transurethral resection. Control arm: Transurethral resection group: under regional or general anaesthesia, the resector is introduced through the urinary tract into the bladder. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Patients of both sexes aged ≥ 18 years.
- Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT.
- Patients with a history of stage CVNMI: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), provided they have a disease-free period of at least 6 months.
- Karnofsky scale score > 70%.
- Patients who agree to participate in the study by signing the informed consent.
- Patients with tumors <3 cm.
Exclusion criteria 8
- Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests.
- Pregnant patients.
- Patients in whom it is foreseen that follow-up is not going to be possible for any reason.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
- Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel.
- Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT.
- Patients will be excluded from the clinical trial if, after TURBT, their pathological anatomy report shows a diagnosis other than papillary type IMIBC (CIS only, benign lesions, muscle invasive bladder carcinoma, etc.).
- Patients with tumors ≥ 3 cm will not be included.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Early recurrence rate of CVNMI.
Secondary endpoints 3
- Adverse events of the drugs administered.
- Demographic characteristics (age, sex).
- Clinical characteristics (TNM classification, risk group, time of evolution, previous treatments received)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Mitomicina Accord 40 mg polvo para solución inyectable y para perfusión EFG
PRD5505248 · Product
- Active substance
- Mitomycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DC03 — MITOMYCIN
- Marketing authorisation
- 82516
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Farmorubicina 50 mg polvo para solución inyectable y para perfusión
PRD499613 · Product
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB03 — EPIRUBICIN
- Marketing authorisation
- 57.201
- MA holder
- PFIZER, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemcitabina Accord 1 g Pó para solução para perfusão
PRD391119 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 38 mg/ml milligram(s)/millilitre
- Max total dose
- 38 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 5229174
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Aurovitas 20 mg/ml concentrado para solución para perfusión
PRD10213565 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- 72.635
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatino Pharmacia 1 mg/ml concentrado para solución para perfusión EFG
PRD4390708 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 62107
- MA holder
- PHARMACIA NOSTRUM S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Farmiblastina 50 mg polvo para solución inyectable
PRD411971 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- 56.172
- MA holder
- PFIZER S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario La Paz
- Sponsor organisation
- Hospital Universitario La Paz
- Address
- Paseo De La Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Luis Piñeiro
Public contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Luis Piñeiro
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruiting | 312 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario La Paz
Urología, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Araba
Urología, Jose Achotegui Kalea S/N, 01009, Vitoria
Hospital Universitario Clinico San Cecilio
Urología, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Germans Trias I Pujol
Urología, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Spain | 2018-05-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-08 | Spain | Acceptable 2024-04-23
|
2024-04-23 |