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Completed Phase 3 Interventional Results available

S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

ClinicalTrials.gov ID: NCT00445601

Public ClinicalTrials.gov record NCT00445601. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 1:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Blinded Study of Immediate Post TURBT Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer. PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer.

Study identification

NCT ID
NCT00445601
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
SWOG Cancer Research Network
Network
Enrollment
406 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 120 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2007 (Type not available)
Primary completion
Jun 2017 (Actual)
Completion
Jun 2017 (Actual)
Last update posted
Jan 18, 2020

2007 – 2017

United States locations

U.S. sites
70
U.S. states
17
U.S. cities
47
Facility City State ZIP Site status
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles California 90048 —
University of California Davis Cancer Center Sacramento California 95817 —
University of Colorado Cancer Center at UC Health Sciences Center Aurora Colorado 80045 —
Urology Center of Colorado Denver Colorado 80211 —
Veterans Affairs Medical Center - Denver Denver Colorado 80220 —
St. Joseph Regional Medical Center Lewiston Idaho 83501 —
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois 60153 —
St. Rose Ambulatory and Surgery Center Great Bend Kansas 67530 —
Hays Medical Center Hays Kansas 67601 —
Hutchinson Hospital Corporation Hutchinson Kansas 67502 —
Kansas City Cancer Centers - West Kansas City Kansas 66112 —
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas 66160-7357 —
Kansas City Cancer Centers - Southwest Overland Park Kansas 66210 —
Mount Carmel Regional Cancer Center Pittsburg Kansas 66762 —
Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas 67401 —
Kansas City Cancer Center - Shawnee Mission Shawnee Mission Kansas 66204 —
St. Francis Comprehensive Cancer Center Topeka Kansas 66606 —
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport Louisiana 71130-3932 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109-0942 —
Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan 48202 —
William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan 48073 —
Truman Medical Center - Hospital Hill Kansas City Missouri 64108 —
Veterans Affairs Medical Center - Kansas City Kansas City Missouri 64128 —
Kansas City Cancer Centers - South Kansas City Missouri 64131 —
Kansas City Cancer Centers - North Kansas City Missouri 64154 —
Kansas City Cancer Centers - East Lee's Summit Missouri 64064 —
CCOP - Montana Cancer Consortium Billings Montana 59101 —
St. Vincent Healthcare Cancer Care Services Billings Montana 59101 —
Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana 59102 —
Billings Clinic - Downtown Billings Montana 59107-7000 —
Bozeman Deaconess Cancer Center Bozeman Montana 59715 —
St. James Healthcare Cancer Care Butte Montana 59701 —
Great Falls Clinic - Main Facility Great Falls Montana 59405 —
Sletten Cancer Institute at Benefis Healthcare Great Falls Montana 59405 —
Northern Montana Hospital Havre Montana 59501 —
St. Peter's Hospital Helena Montana 59601 —
Glacier Oncology, PLLC Kalispell Montana 59901 —
Kalispell Medical Oncology at KRMC Kalispell Montana 59901 —
Kalispell Regional Medical Center Kalispell Montana 59901 —
Montana Cancer Specialists at Montana Cancer Center Missoula Montana 59807-7877 —
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana 59807 —
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York 14642 —
Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina 28232-2861 —
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195 —
Oklahoma University Cancer Institute Oklahoma City Oklahoma 73104 —
Bay Area Hospital Coos Bay Oregon 97420 —
Knight Cancer Institute at Oregon Health and Science University Portland Oregon 97239-3098 —
Brooke Army Medical Center Fort Sam Houston Texas 78234-6200 —
M. D. Anderson Cancer Center at University of Texas Houston Texas 77030-4009 —
Baylor University Medical Center - Houston Houston Texas 77030 —
Methodist Hospital Houston Texas 77030 —
Veterans Affairs Medical Center - Houston Houston Texas 77030 —
Wilford Hall Medical Center Lackland Air Force Base Texas 78236 —
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas 78209 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229-3900 —
Cancer Therapy and Research Center San Antonio Texas 78229 —
University Hospital - San Antonio San Antonio Texas 78229 —
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue Washington 98004 —
Providence Centralia Hospital Centralia Washington 98531-9027 —
Providence Regional Cancer Partnership Everett Washington 98201 —
St. Francis Hospital Federal Way Washington 98003 —
Providence St. Peter Hospital Regional Cancer Center Olympia Washington 98506-5166 —
Good Samaritan Cancer Center Puyallup Washington 98372 —
Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington 98405-3004 —
Allenmore Hospital Tacoma Washington 98405 —
CCOP - Northwest Tacoma Washington 98405 —
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington 98405 —
Madigan Army Medical Center - Tacoma Tacoma Washington 98431 —
St. Clare Hospital Tacoma Washington 98499 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00445601, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 18, 2020 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00445601 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →