Intravesical Chemotherapy Treatment of Superficial Bladder Cancer

Intravesical Gemcitabine Therapy in Intermediate Risk Superficial Bladder Cancer: A Phase II Study With the Marker Lesion

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00491114

Enrollment

Registered

2007-06-25

Start date

2003-07-31

Completion date

2004-08-31

Last updated

2007-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Neoplasms

Brief summary

This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.

Interventions

DRUGGemcitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Superficial bladder cancer * No prior chemotherapy

Exclusion criteria

* Grade 3 tumors * Papillary tumors invading connective tissue * Significant urologic disease, possible interfering with intravesical therapy

Design outcomes

Primary

Measure	Time frame
To evaluate the response rate	—

Secondary

Measure	Time frame
To define the relapse free survival	—
To assess toxicity profile	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026