HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR)

Conditions

Non Muscle Invasive Bladder Cancer

Guerrero-Ramos F, González-Padilla DA, González-Díaz A, de la Rosa-Kehrmann F, Rodríguez-Antolín A, Inman BA, Villacampa-Aubá F.

2022-01-1741 citations

10.1007/s00345-022-03928-1

PD03-01 BCG VS CHEMOHYPERTHERMIA WITH MITOMYCIN C FOR HIGH-RISK NON-MUSCLE INVASIVE BLADDER CARCINOMA: PRELIMINARY RESULTS OF HIVEC-HR RANDOMIZED CLINICAL TRIAL

Félix Guerrero‐Ramos, Daniel A. González‐Padilla, Alejandro González-Díaz, Felipe Villacampa, Marta Rodríguez-Izquierdo et al. (8 authors)

The Journal of Urology2020-04-01

10.1097/ju.0000000000000823.01

MP43-08 BCG VS CHEMOHYPERTHERMIA WITH MITOMYCIN C FOR HIGH-RISK NON-MUSCLE INVASIVE BLADDER CARCINOMA: PRELIMINARY RESULTS OF HIVEC-HR RANDOMIZED CLINICAL TRIAL

Félix Guerrero‐Ramos, Daniel A. González‐Padilla, Alejandro González-Díaz, J.M. Duarte-Ojeda, N. Miranda-Utrera et al. (7 authors)

The Journal of Urology2019-04-012 citations

10.1097/01.ju.0000556231.44325.78

Interventions

Trade Name: Mitomycin-C Product Name: Mitomycin-C Pharmaceutical Form: Intravesical solution INN or Proposed INN: MITOMYCIN CAS Number: 50-07-7 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients operated of non invasive bladder tumour that meet high risk criteria as per EORTC risk categories 2. Above 18 years old 3. Accept to participate in the trial and sign the consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: 1. Patients with invasive lesions or CIS 2. Hypersensitivity or allergy to MMC 3. History of severe adverse reaction to BCG 4. Epithelial cells carcinoma involving prostatic urethra or upper urinary tract 5. Patients with tumors histologically different than transitional cell carcinoma 6. Patients that for any reason should receive simultaneous chemotherapy 7. Withdrawal of CI 8. Pregnant or lactating or women of childbearing age who do not want or can not use non-hormonal contraceptives 9. Urethral stenosis that contraindicates catheterization for the instillation 10. Treatment with immunosuppressants that contraindicates BCG therapy

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 24 months after last instillation;Main Objective: Evaluate disease free survival time after 24 months follow up of TURBT followed by HIVEC compared with TURBT followed by standard BCG therapy;Secondary Objective: 1. Time to progression of HIVEC vs. BCG 2. Cancer specific survival of HIVEC vs BCG 3. Adverse Events of HIVEC vs BCG 4. QoL of HIVEC vs. BCG;Primary end point(s): Disease Free survival after 24 months follow up	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 24 months after last instillation;Main Objective: Evaluate disease free survival time after 24 months follow up of TURBT followed by HIVEC compared with TURBT followed by standard BCG therapy;Secondary Objective: 1. Time to progression of HIVEC vs. BCG 2. Cancer specific survival of HIVEC vs BCG 3. Adverse Events of HIVEC vs BCG 4. QoL of HIVEC vs. BCG;Primary end point(s): Disease Free survival after 24 months follow up

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Time to progression 2. Cancer specific survival 3. Adverse Events of HIVEC compared with BCG 4. Quality of Life;Timepoint(s) of evaluation of this end point: 24 months after the last instillation	—

Countries

Spain

Contacts

Public ContactHospital Universitario 12 Octubre

Dr. Felipe Villacampa

fvillacampa@yahoo.es+34637569593

Outcome results

None listed