NCT01697306

Brief Summary

To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
Last Updated

January 30, 2025

Status Verified

September 1, 2012

Enrollment Period

4.5 years

First QC Date

September 21, 2012

Last Update Submit

January 28, 2025

Conditions

Bladder Cancer

Keywords

non muscle invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

  • quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG

    1 year

Secondary Outcomes (2)

  • comparison of the short term efficacy of the two treatments in terms of recurrence

    1 year

  • comparison of the short term efficacy of the two treatments in terms of progression

    1 year

Study Arms (2)

Gemcitabine-arm

ACTIVE COMPARATOR

7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year

Drug: Gemcitabine 2 g

BCG-arm

ACTIVE COMPARATOR

7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months

Drug: BCG Vaccine

Interventions

Gemcitabine 2 gDRUG

six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline

Also known as: Gemzar, Eli Lilly SpA
Gemcitabine-arm
BCG VaccineDRUG

six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline

Also known as: BCG Connaught 1/3 dose
BCG-arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, \>3 cm in diameter)
  • WHO performance status ≤2
  • age ≤85years
  • BCG naive
  • patients not treated with intravesical chemotherapy in the last 3 months.

You may not qualify if:

  • presence of T1G3 or CIS
  • preoperative urinary cytology positive for high-grade atypia
  • inadequate bone marrow reserve (white blood cells \<3 x 109/l, platelets \<100 x 109/l)
  • history of genito-urinary tuberculosis
  • presence of uncontrolled urinary infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O.U. San Giovanni Battista Molinette

Torino, TO, 10126, Italy

Location

Related Publications (2)

  • Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E, Rodriguez RH, Gomez JM, Martin MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadan M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urologico Espanol de Tratamiento Oncologico (CUETO). Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol. 2005 Oct;174(4 Pt 1):1242-7. doi: 10.1097/01.ju.0000173919.28835.aa.

    PMID: 16145378BACKGROUND

  • Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guerin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int. 2010;84(1):23-7. doi: 10.1159/000273461. Epub 2010 Feb 17.

    PMID: 20173364BACKGROUND

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder Neoplasms

Interventions

GemcitabineBCG VaccineBCG Connaught

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTuberculosis VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Paolo Gontero, Professor

    A.O.U. San Giovanni Battista Molinette

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 2, 2012

Study Start

September 1, 2006

Primary Completion

March 1, 2011

Study Completion

May 1, 2012

Last Updated

January 30, 2025

Record last verified: 2012-09

Locations

IT(1)