Clinical trial to evaluate recurrence in bladder cancer using two differents strategies of treatment: chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program or post resection treatment with mitomycin C in normothermia

Randomized prospective clinical trial to evaluate the rate of early recurrence in bladder cancer in non-muscle invasive between the chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program and post resection treatment with mitomycin C in normothermia.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005151-27-ES

Enrollment

Unknown

Registered

2016-03-18

Start date

2016-05-06

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 18.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 18.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: MITOMYCIN-C 40 mg Polvo para solución inyectable Pharmaceutical Form: Trade Name: MITOMYCIN-C 40 mg Polvo para solución inyectable Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: More than 18 years vesical tumor =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Known hipersensibility to MMC or excipients. - Pregnant or lactancy - Recent Transuretral resection ( 3 cm - to have more than 8 tumors - Severe cardiopathy - Chronic renal insufficinecy - Trombocitopenia ( <100.000 platets) ,coagulation disorders and bleeding tendency for other causes.

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the recurrence rate of the intravesical cancer non invasive at 12, 18 and 24 months post MMC instillation using hiperthermia pre uretral resection or normothermia post uretral resection;Secondary Objective: To Evaluate tolerance and safety in patients treated with QH MMC instillations of pre-RTU-V patients. To Evaluate tolerance of early instillation after TUR-V MMC (standard of care) To Explore possible predictors of response (in terms of recurrence and disease progression) to treatment with MMC QH of previous patients to outpatient RTU-V. To Analyze the efficiency of treatment with QH and MMC of patients prior to the RTU-V outpatients. To analyze the degree of satisfaction of patients after completion of the procedure on an outpatient basis. To Compare the quality of life of patients before and after treatment and its possible impact on sexual life. To Explore possible predictors of income after QH RTU-bladder prior to outpatients.;Primary end point(s): tumoral recurrence post uretral resection;Timepoint(s) of evaluation of this end point: at 12, 18 and 24 months.	—

Measure

Time frame

Main Objective: to evaluate the recurrence rate of the intravesical cancer non invasive at 12, 18 and 24 months post MMC instillation using hiperthermia pre uretral resection or normothermia post uretral resection;Secondary Objective: To Evaluate tolerance and safety in patients treated with QH MMC instillations of pre-RTU-V patients. To Evaluate tolerance of early instillation after TUR-V MMC (standard of care) To Explore possible predictors of response (in terms of recurrence and disease progression) to treatment with MMC QH of previous patients to outpatient RTU-V. To Analyze the efficiency of treatment with QH and MMC of patients prior to the RTU-V outpatients. To analyze the degree of satisfaction of patients after completion of the procedure on an outpatient basis. To Compare the quality of life of patients before and after treatment and its possible impact on sexual life. To Explore possible predictors of income after QH RTU-bladder prior to outpatients.;Primary end point(s): tumoral recurrence post uretral resection;Timepoint(s) of evaluation of this end point: at 12, 18 and 24 months.

—

Secondary

Measure	Time frame
Secondary end point(s): adverse events, predictor factors in the treatment response and hospitalization, life quality and sexual health;Timepoint(s) of evaluation of this end point: at 12, 18 and 24 months	—

Countries

Spain

Contacts

Public ContactUCICEC

Hospital Universitario de canarias

aaldperh@gobiernodecanarias.org34922678117

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026