Addition of hyaluronate to mitomycin vs mitomycin in low risk bladder cancer

Open clinical trial to evaluate the efficacy of intravesical instillation of hyaluronate added to early instillation of mitomycin vs early instillation of mitomycin in patients suffering from low risk not muscle-infiltrating bladder cancer - Efficacy of hyaluronate/condroitinsolfate (Ialuril Prefill) added on top of Mitomycin C vs Mitomy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003813-92-IT

Enrollment

120

Registered

2018-02-22

Start date

2017-01-25

Completion date

Unknown

Last updated

2018-02-26

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

Conditions

Low risk not muscle-infiltrating bladder neoplasia MedDRA version: 20.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: MITOMYCIN C Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Both gender with 18-80 years of age Physiological/Surgical Menopause Histological diagnosis of transitional vesical neoplasia Patients with vesical neoplasia at low risk according to EORTC Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Hypersensitivity either to Ialurill Prefill or to one of its component Hypersensitivity and controindications to Mitomycin C Ongoing macroematuria Suspected bladder drill Patients with vesical neoplasia at high risk according to EORTC Capacity of bladder < 300 cc

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the efficacy, in terms of absence of relapse, of the intravesical instillation of hyaluronate/condroitinsolfate as add-on within 12 hours from early intravesical instillation of Mitomycin C vs early instillation of Mitomycin C in monotherapy within 24 hours from endoscopic resection,in the therapy of not muscle-infiltrating bladder cancer, in patients with low risk according to EORTC.;Secondary Objective: Evaluation of the efficacy, in terms of free time of disease, time of relapse and rate of progression , of the intravesical instillation of hyaluronate/condroitinsolfate as add-on within 12 hours from early intravesical instillation of Mitomycin C vs early instillation of Mitomycin C in monotherapy, in the therapy of not muscle-infiltrating bladder cancer, in patients with low risk acording to EORTC.;Primary end point(s): Evaluation of number and porcentage of patients that show absence of relapse after 24 months from the add on intravesical administration of hyaluronate/condrotinsolfate aftter early intravesical instillation of Mitomycin C vs intravesical instillation of Mitomycin C in monotherapy;Timepoint(s) of evaluation of this end point: 24 months	—

Measure

Time frame

Main Objective: Evaluation of the efficacy, in terms of absence of relapse, of the intravesical instillation of hyaluronate/condroitinsolfate as add-on within 12 hours from early intravesical instillation of Mitomycin C vs early instillation of Mitomycin C in monotherapy within 24 hours from endoscopic resection,in the therapy of not muscle-infiltrating bladder cancer, in patients with low risk according to EORTC.;Secondary Objective: Evaluation of the efficacy, in terms of free time of disease, time of relapse and rate of progression , of the intravesical instillation of hyaluronate/condroitinsolfate as add-on within 12 hours from early intravesical instillation of Mitomycin C vs early instillation of Mitomycin C in monotherapy, in the therapy of not muscle-infiltrating bladder cancer, in patients with low risk acording to EORTC.;Primary end point(s): Evaluation of number and porcentage of patients that show absence of relapse after 24 months from the add on intravesical administration of hyaluronate/condrotinsolfate aftter early intravesical instillation of Mitomycin C vs intravesical instillation of Mitomycin C in monotherapy;Timepoint(s) of evaluation of this end point: 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of number and porcentage of patients that show absence of relapse after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of free time from disease after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of time of relapse after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of time of progression after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of rate and entity of adverse events and incidents after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C;Timepoint(s) of evaluation of this end point: 3, 9, 15 months or absence of relapse 3, 9, 15 and 24 months for free time from disease, time of relapse, time of progression, rate/entity of AEs/incident	—

Measure

Time frame

Secondary end point(s): Evaluation of number and porcentage of patients that show absence of relapse after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of free time from disease after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of time of relapse after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of time of progression after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C Evaluation of rate and entity of adverse events and incidents after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C;Timepoint(s) of evaluation of this end point: 3, 9, 15 months or absence of relapse 3, 9, 15 and 24 months for free time from disease, time of relapse, time of progression, rate/entity of AEs/incident

—

Countries

Italy

Contacts

Public ContactCRO

InformaPRO Srl

segreteria@informa.pro065758926

Outcome results

None listed

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