NCT00213655

Brief Summary

Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

8.9 years

First QC Date

September 14, 2005

Last Update Submit

July 30, 2014

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumoral response

    Tumoral response assessed at M36

    Month 36

Secondary Outcomes (1)

  • Tumoral response

    Month 24

Study Arms (2)

Daily instillation of BCG for 3 weeks then every 6 months

Effect of daily instillation of BCG (27 mg) for 3 weeks then one instillation of BCG (27 mg) every 6 months for 36 months on bladder tumor recurrence

Biological: bladder tumor recurrence

Daily instillation of BCG for 2 weeks then every 3 months

Effect of daily instillation of BCG (27 mg) for 2 weeks then one instillation of BCG (27 mg) every 3 months for 36 months on bladder tumor recurrence

Biological: bladder tumor recurrence

Interventions

bladder tumor recurrenceBIOLOGICAL

bladder tumor recurrence assessed by clinical and biological exams

Daily instillation of BCG for 2 weeks then every 3 monthsDaily instillation of BCG for 3 weeks then every 6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bladder Cancer

You may qualify if:

  • Ta and T1 bladder tumors

You may not qualify if:

  • BCG contra-indications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Nicolle, University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Christian PFISTER, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

June 1, 2004

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

FR(1)