a phase III randomised trial of intravesical chemotherapy vs thermo-chemotherapy in intermediate risk non-muscle invasive bladder cancer

a phase III randomised trial of intravesical chemotherapy vs thermo-chemotherapy in intermediate risk non-muscle invasive bladder cancer - CHIB study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39804

Enrollment

212

Registered

2015-03-03

Start date

2015-09-08

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

non-muscle invasive bladder cancer superficial bladder cancer

Interventions

The intervention will be: Arm 1 (standard arm): Following a complete resection of the bladder tumour(s): 6 weekly courses with intravesical chemotherapy using Mitomycin C 40 mg followed by a mainten

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patients with an intermediate risk non-muscle invasive urothelial carcinoma of the bladder. * WHO performance status of 0-2 * Life expectancy of more than 24 months * Written informed consent * Age * 18 years

Exclusion criteria

Exclusion criteria: * Intravesical mitomycin C during the last 6 months * Previous treatment with Bacillus Calmette Guerin * Bladder tumours other than urothelial carcinoma * Known allergy to MMC * Small bladder volume; less than 100 cc * Urinary incontinence * Hip prosthesis * Pacemaker/ICD * Incapability of inserting catheters for thermometry or measuring temperatures in bladder or anal canal * Inability to comply with the treatment protocol

Design outcomes

Primary

Measure	Time frame
1. Recurrence free survival	—

Secondary

Measure	Time frame
2. Progression rate 3. Toxicity 4. Functional bladder capacity 5. Quality of Life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)