Treatment of bladder cancer with gemcitabine and docetaxel (for people not responding to Bacillus Calmette-Guerin (BCG) treatment)

Sequential instillations with gEmCitaBin and dOcetaxel for BCG-unrespoNsive and BCG-intolerant blaDdercancer – SECOND-trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17499170

Enrollment

100

Registered

2023-02-15

Start date

2023-03-01

Completion date

Unknown

Last updated

2025-09-08

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 Cancer

Interventions

The prospective trial investigates intravesical administration of sequential gemcitabine and docetaxel (gem/doc) including six weekly induction courses and maintenance installations once a month for 9

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. BCG-unresponsive NMIBC 2. BCG-intolerant NMIBC 3. BCG-recurrent NMIBC

Exclusion criteria

Exclusion criteria: 1. Allergy to either gem or doc 2. Chronic urinary catheter 3. Severe incontinence affecting possibilities to retain intravesical instillations

Design outcomes

Primary

Measure	Time frame
1. Complete remission (CR) at 24 months measured using patient records 2. Recurrence-Free Survival (RFS) and Progression-Free Survival (PFS) assessed by cystoscopies and voided urinary cytology during follow-up.	—

Secondary

Measure	Time frame
1. Health-related quality of life is assessed by EORTC-QLQ30-NMIBC24 before induction treatment, four weeks after induction chemotherapy at 10 weeks and four weeks after completion of all 9 maintenance installations. 2. Side-effects are monitored before each installation by the national side-effect questionnaire. 3. Health economic assessment is performed by applying data from the EQ-5D-5L and EORTC-QLQ30-NMIBC24 questionnaires at the end of the study	—

Measure

Time frame

1. Health-related quality of life is assessed by EORTC-QLQ30-NMIBC24 before induction treatment, four weeks after induction chemotherapy at 10 weeks and four weeks after completion of all 9 maintenance installations. 2. Side-effects are monitored before each installation by the national side-effect questionnaire. 3. Health economic assessment is performed by applying data from the EQ-5D-5L and EORTC-QLQ30-NMIBC24 questionnaires at the end of the study

—

Countries

Sweden

Outcome results

None listed

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