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Assessment of the therapeutic effect of intravesical Gemcitabine in patients with bladder cancer.

Assessment of the therapeutic effect of intravesical Gemcitabine compared with intravesical BCG in non-muscle invasive urothelial carcinoma of the bladder, subgroups of intermediate-risk

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200402046915N1
Enrollment
110
Registered
2020-10-04
Start date
2020-06-21
Completion date
Unknown
Last updated
2020-10-06

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

Conditions

Bladder Cancer. Malignant neoplasm of bladder, unspecified

Interventions

Intervention 1: Intervention group: Patients with non-muscle invasive bladder cancer subgroup of intermediate-risk who undergo 6 intravesical injections of 1 g of vial Gemcitabine for 2 hours at one-w

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All the patients with bladder cancer who are not candidates for chemotherapy or bladder removal surgery. Patients with no history of TURT surgery. Patients have no history of intravesical injections. Patients respond to the initial pathology under the moderate risk group with no muscle involvement.

Exclusion criteria

Exclusion criteria: Patients with ruptured bladder during TURT surgery. Patients with immunodeficiency. Patients who are pregnant. Patients who are unable to perform TURT due to urethral stricture or urethral obstruction. Patients with a history of intravesical injections.

Design outcomes

Primary

MeasureTime frame
Recurrence of bladder cancer. Timepoint: First, a cystoscopy will be performed one month after the last injection into the bladder. Then, in the first year, it will be evaluated by cystoscopy every 3 months, and then every 6 months by cystoscopy. Method of measurement: Direct observation inside the bladder through cystoscopy.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Ali Hojjati

Shahid Beheshti University of Medical Sciences

sah.hojjati@sbmu.ac.ir+98 21 2271 8001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026