Prospective randomised study of the impact of preoperative administration of mitomycin-C by electromotive drug administration (EMDA) in patients with non-muscle invasive urothelial carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Apr 2023 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fundacion FISABIO · Hospital General Universitari de Castelló

External identifiers

EU CT number

2024-510867-42-00

EudraCT number

2022-004112-28

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Determine the impact of electromotive drug administration (EMDA) with mitomycin C (MMC) before transurethral resection (TUR) in patients with primary and recurrent low-grade non-muscle invasive bladder tumors and evaluate the recurrence rate (understanding recurrence as the appearance of a new non-muscle invasive bladder tumor with staging T grade equal to or lower than the baseline tumor) and/or progression (understanding progression as the appearance of a new bladder tumor with staging T grade higher than the baseline tumor) and the time to first event in patients with NMIBC who receive MMC+EMDA before TUR compared to passive diffusion MMC instillation after TUR.

Secondary objectives 4

1. Analyze the progression rate and the time to progression in patients with EMDA before TUR compared to passive diffusion MMC instillation after TUR.
2. Evaluate the tolerance of preoperative MMC+EMDA treatment.
3. Quantify the percentage of patients in each group who complete the treatment (understanding full treatment as the administration of preoperative EMDA+MMC or postoperative passive diffusion MMC)
4. Evaluate the impact of inflammatory markers (neutrophil/lymphocyte ratio and platelet/lymphocyte ratio) on the risk of recurrence and progression of non-muscle invasive urothelial carcinoma.

Conditions and MedDRA coding

non-muscle invasive bladder tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients with suspected urothelial cell carcinoma Ta or T1 based on cystoscopy and/or ultrasound.
2. Primary papillary tumor
3. Recurrent low-grade single or multiple tumors.
4. Patients with preserved renal function (serum creatinine < 1.12 mg/dl) and normal liver function (gamma-glutamyl transpeptidase ≤ 51 U/L, alanine aminotransferase ≤ 50 U/L, and total bilirubin ≤ 22 μmol/L).
5. Documented and signed authorization to participate in clinica trial

Exclusion criteria 16

1. Patients with histology different from urothelial carcinoma after the pathological analysis of the surgical specimen.
2. Patients with bladder cancer staged ≥ T2.
3. Patients with synchronous upper tract urothelial carcinoma (UTUC)
4. Allergy to Mitomycin-C.
5. Patients who, in the investigator's opinion, are unable to complete the study questionnaires or attend follow-up visits.
6. Patients with recurrent high-grade tumor.
7. Patients with recurrent CIS.
8. Reduced bladder capacity (less than 200 cc)
9. History of high-grade bladder tumor or CIS.
10. History of untreated urinary tract infection.
11. Severe systemic infection.
12. Treatment with radiotherapy or chemotherapy.
13. Treatment with immunosuppressants.
14. Patients with a pacemaker or implantable cardioverter-defibrillator (ICD).
15. Other malignancies within the 5 years prior to study inclusion (except for effectively treated skin cancer or localized cervical cancer).
16. Pregnancy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Recurrence free survival
2. Progresion free survival

Secondary endpoints 3

1. Total cases of adverse effects by group
2. Therapeutic completion rate by group
3. Impact of recurrence free survival and progresion free survival depending on inflammatory response parameters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Sponsor organisation

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Address

Avenida Cataluna No 21

City

Valencia

Postcode

46020

Country

Spain

Scientific contact point

Organisation

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Contact name

Guillem Abad Carratalá

Public contact point

Organisation

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Contact name

Guillem Abad Carratalá

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications