Clinical trial • Phase IV • Oncology

MITOMYCIN for Non-muscle invasive bladder cancer

Phase IV trial of MITOMYCIN for Non-muscle invasive bladder cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-muscle invasive bladder cancer
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
08-04-2024
First CTIS Authorization Date
23-04-2024

Trial design

Randomised, open-label, control arm: transurethral resection group (turbt) without neoadjuvant intravesical chemotherapy. experimental arm: intravesical chemotherapy instillation prior to turbt — mitomycin c 40 mg diluted in 40 ml instilled (kept in bladder for 15 minutes) as recommended; in case of mitomycin c shortage, the following drugs/doses may be used: epirubicin 50 mg in 50 cc; gemcitabine 1 g in 50 cc; doxorubicin (adriamycin/farmiblastina) 50 mg in 50 cc; cisplatin 30 mg in 50 cc; docetaxel 40 mg in 40 cc. Phase IV trial in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Control arm: Transurethral resection group (TURBT) without neoadjuvant intravesical chemotherapy. Experimental arm: Intravesical chemotherapy instillation prior to TURBT — Mitomycin C 40 mg diluted in 40 mL instilled (kept in bladder for 15 minutes) as recommended; in case of Mitomycin C shortage, the following drugs/doses may be used: Epirubicin 50 mg in 50 cc; Gemcitabine 1 g in 50 cc; Doxorubicin (Adriamycin/Farmiblastina) 50 mg in 50 cc; Cisplatin 30 mg in 50 cc; Docetaxel 40 mg in 40 cc.
Target Sample Size
312
Trial Duration For Participant
1825

Eligibility

Recruits 312 No vulnerable population selected; informed consent required: 'Patients who agree to participate in the study by signing the informed consent.'.

Pregnancy Exclusion
Pregnant patients.
Vulnerable Population
No vulnerable population selected; informed consent required: 'Patients who agree to participate in the study by signing the informed consent.'

Inclusion criteria

  • {"criterion_text":"- Patients of both sexes aged ≥ 18 years.\n- Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT.\n- 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.\n- Karnofsky scale score > 70%.\n- Patients who agree to participate in the study by signing the informed consent.\n- Patients with tumors <3 cm."}

Exclusion criteria

  • {"criterion_text":"- Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests.\n- Pregnant patients.\n- Patients in whom it is foreseen that follow-up is not going to be possible for any reason.\n- Patients who for any reason should not be included in the study according to the evaluation of the research team.\n- Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel.\n- Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT.\n- 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.).\n- Patients with tumors ≥ 3 cm will not be included."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Early recurrence rate of CVNMI.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Adverse events of the drugs administered.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Demographic characteristics (age, sex).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Clinical characteristics (TNM classification, risk group, time of evolution, previous treatments received)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
312
Recruitment Window Months
132
Consent Approach
Informed consent required from participants: 'Patients who agree to participate in the study by signing the informed consent.' No assent process or age-specific consent documents described. Translations of trial documents are available in Spanish (translations shown for titles), but no explicit list of consent form languages is provided.

Geography

Total Number Of Sites
4
Total Number Of Participants
312

Spain

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
23-04-2024
Processing Time Days
41
Number Of Sites
4
Number Of Participants
312

Sites

Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Urología
Contact Person Name
Miguel Arrabal
Site Name
Hospital Universitario La Paz
Department Name
Urología
Contact Person Name
Luis Piñeiro
Contact Person Email
luis.mpineiro@salud.madrid.org
Site Name
Hospital Universitario Araba
Department Name
Urología
Contact Person Name
Josep Campa
Contact Person Email
jmcampa@gmx.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Urología
Contact Person Name
Oscar Buisan
Contact Person Email
obuisan2903@gmail.com

Sponsor

Primary sponsor

Full Name
Hospital Universitario La Paz
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Mitomicina Accord 40 mg polvo para solución inyectable y para perfusión EFG
Active Substance
MITOMYCIN
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Authorisation Status
Authorised (marketing authorisation number 82516)
Starting Dose
40 mg diluted in 40 mL (instilled for 15 minutes)
Frequency
Single instillation prior to TURBT
Maximum Dose
40 mg
Investigational Product Name
Farmorubicina 50 mg polvo para solución inyectable y para perfusión
Active Substance
EPIRUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Authorisation Status
Authorised (marketing authorisation number 57.201)
Starting Dose
50 mg in 50 cc of physiological saline solution
Frequency
Single instillation prior to TURBT
Maximum Dose
50 mg
Investigational Product Name
Docetaxel Aurovitas 20 mg/ml concentrado para solución para perfusión
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Authorisation Status
Authorised (marketing authorisation number 72.635)
Starting Dose
40 mg dissolved in 40 cc of sterile water
Frequency
Single instillation prior to TURBT
Maximum Dose
40 mg
Investigational Product Name
Cisplatino Pharmacia 1 mg/ml concentrado para solución para perfusión EFG
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Authorisation Status
Authorised (marketing authorisation number 62107)
Starting Dose
30 mg dissolved in 50 cc of physiological saline solution
Frequency
Single instillation prior to TURBT
Maximum Dose
30 mg
Investigational Product Name
Farmiblastina 50 mg polvo para solución inyectable
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Authorisation Status
Authorised (marketing authorisation number 56.172)
Starting Dose
50 mg in 50 cc of physiological saline solution
Frequency
Single instillation prior to TURBT
Maximum Dose
50 mg
Investigational Product Name
Gemcitabina Accord 1 g Pó para solução para perfusão
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
Intravesical use
Route
Intravesical
Authorisation Status
Authorised (marketing authorisation number 5229174)
Starting Dose
1 g dissolved in 50 cc of physiological saline solution
Frequency
Single instillation prior to TURBT
Maximum Dose
1 g

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