NCT01697306 is a Phase 2 clinical trial of Gemcitabine 2 g in Bladder Cancer, sponsored by A.O.U. Città della Salute e della Scienza.

Who is sponsoring NCT01697306?

NCT01697306 is sponsored by A.O.U. Città della Salute e della Scienza.

What drugs are being tested in NCT01697306?

Interventions in NCT01697306: Gemcitabine 2 g, BCG Vaccine.

What condition does NCT01697306 study?

NCT01697306 studies Bladder Cancer.

Is NCT01697306 still recruiting?

NCT01697306 is currently completed. Last updated 28 January 2025.

Last reviewed 2025-01-28 · How we verify

NCT01697306

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.

Completed Phase 2 Last updated 28 January 2025

What this trial tests

Phase 2 trial testing Gemcitabine 2 g in Bladder Cancer in 120 participants. Completed in 1 May 2012.

Timeline

1 September 2006

Primary endpoint
1 March 2011

1 May 2012

Quick facts

Lead sponsor	A.O.U. Città della Salute e della Scienza
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	120
Start date	1 September 2006
Primary completion	1 March 2011
Estimated completion	1 May 2012
Sites	1 location across Italy

Drugs / interventions tested

Gemcitabine 2 g — full drug profile →
BCG Vaccine — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

A.O.U. Città della Salute e della Scienza — full company profile →

Who can join

Adults 18 to 85, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG
Time frame: 1 year

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Intravesical gemcitabine for non-muscle invasive bladder cancer.
Han MA, Maisch P, Jung JH, Hwang JE, et al · · 2021 · cited 26× · PMID 34125951 · DOI 10.1002/14651858.cd009294.pub3

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Other A.O.U. Città della Salute e della Scienza trials

Trials by the same sponsor.

NCT07535125 — IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN · not yet recruiting
NCT07017192 — OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study · NA · recruiting
NCT06690567 — Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention · unknown
NCT06548438 — The Impact of PDD During TURB for NMIBC · Phase 4 · not yet recruiting
NCT07245524 — PeriOPerative Spine Surgery COntrol Pain (POPSSCOP) Study: Intrathecal Morphine vs Erector Spinae Plane Block for Postop · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01697306 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by A.O.U. Città della Salute e della Scienza
Last refreshed: 28 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01697306.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing