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Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer

NCT ID: NCT00696579

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer

Detailed Description

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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 months.

Conditions

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Bladder Cancer

Keywords

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BCG Gemcitabine Intravesical Therapy Superficial Transitional Cell carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

Group Type ACTIVE_COMPARATOR

BCG

Intervention Type DRUG

6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

2

14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours

Interventions

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BCG

6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

Intervention Type DRUG

gemcitabine

14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary diagnosis of high risk superficial bladder cancer according to EAU guidelines (http://www.eortc.be/tools/bladdercalculator/),
* 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 months;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Of Perugia

OTHER

Sponsor Role lead

Locations

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1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy

Perugia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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EC_ML_003

Identifier Type: -

Identifier Source: org_study_id