Know Cancer

forgot password

BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Bladder Cancer

Thank you

Trial Information

BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study

This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary
urban teaching University Urological Department regarding sixty-four patients with high-risk
superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions
(gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated
weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at
3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a
weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36

Inclusion Criteria:

- Primary diagnosis of high risk superficial bladder cancer according to EAU
guidelines (,

- Having never been treated with other intravesical chemotherapeutic agents,

- And to consent to participate to the study

Exclusion Criteria:

- Concomitant tumours;

- Urinary tract infections (UTI);

- Altered function of the liver, kidneys and/or bone marrow;

- Major cardiovascular diseases;

- Life expectancy of less than 1 year;

- Intravesical chemotherapy in the previous 3 months or immunotherapy in the previous 6

- Systemic chemotherapy and pelvic radiotherapy prior to TURB, and any condition that
in the judgment of the investigators would interfere with the subject's ability to
provide informed consent, comply with study instructions, place the subject at
increased risk, or which might confound interpretation of study results.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

The primary outcome measure consists of evaluation of recurrence and progression rates as they were detected by follow-up tools. Interval before recurrence and progression were also considered primary end-points

Safety Issue:



Italy: Ministry of Health

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Bladder Cancer
  • BCG
  • Gemcitabine
  • Intravesical
  • Therapy
  • Superficial
  • Transitional
  • Cell carcinoma
  • Urinary Bladder Neoplasms