Trial · NCT00445601

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

NCT00445601, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2018-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer. Trials, record NCT00445601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00445601

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
NCT number: NCT00445601
Status: Completed
Phases: Phase 3
Enrollment: 406 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Bladder Cancer
Interventions: gemcitabine hydrochloride, placebo
First posted: 2007-03-09
Last updated: 2020-01-18
Results first posted: 2018-04-24

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Recurrence Rate	Up to 2 Years	Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.
Secondary	Rate of Progression to Muscle Invasive Disease at 4 Years	4 years	From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.
Secondary	Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)	Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug
Secondary	Rate of Disease Worsening Over 2 Years	Up to 2 years	Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Recurrence Rate	Up to 2 Years	Intent-to-Treat population	percentage of patients with recurrence	NUMBER
SECONDARY	Rate of Progression to Muscle Invasive Disease at 4 Years	4 years	Intent-to-Treat Population	percentage of patients with progression	NUMBER
SECONDARY	Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)	All eligible patients who received instillation after TURBT and reported adverse events	Participants	NUMBER
SECONDARY	Rate of Disease Worsening Over 2 Years	Up to 2 years	TURBT data after patients stopped trial was not collected.

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Disease Recurrence Rate	Arm I		27.86	percentage of patients with recurrence
Disease Recurrence Rate	Arm II		40	percentage of patients with recurrence
Rate of Progression to Muscle Invasive Disease at 4 Years	Arm I		2.49	percentage of patients with progression
Rate of Progression to Muscle Invasive Disease at 4 Years	Arm II		4.39	percentage of patients with progression
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Arm I: Gemcitabine	Bladder spasms	0	Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Arm II: Placebo	Bladder spasms	1	Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Arm I: Gemcitabine	Hemorrhage, GU - Bladder	1	Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Arm II: Placebo	Hemorrhage, GU - Bladder	0	Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Arm I: Gemcitabine	Hemorrhage, GU - Urinary NOS	2	Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms	Arm II: Placebo	Hemorrhage, GU - Urinary NOS	1	Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I	201
Overall Study	STARTED	Arm II	205
Overall Study	Received TURBT	Arm I	190
Overall Study	Received TURBT	Arm II	193
Overall Study	COMPLETED	Arm I	168
Overall Study	COMPLETED	Arm II	177
Overall Study	NOT COMPLETED	Arm I	33
Overall Study	NOT COMPLETED	Arm II	28

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Arm I: Gemcitabine	11	165
other	Nausea	Gastrointestinal disorders	Arm II: Placebo	3	174
other	Vomiting	Gastrointestinal disorders	Arm I: Gemcitabine	9	165
other	Vomiting	Gastrointestinal disorders	Arm II: Placebo	1	174
other	Bladder spasms	Renal and urinary disorders	Arm I: Gemcitabine	13	165
other	Bladder spasms	Renal and urinary disorders	Arm II: Placebo	9	174
other	Hemorrhage, GU - Urinary NOS	Renal and urinary disorders	Arm I: Gemcitabine	16	165
other	Hemorrhage, GU - Urinary NOS	Renal and urinary disorders	Arm II: Placebo	19	174
other	Pain - Bladder	Renal and urinary disorders	Arm I: Gemcitabine	23	165
other	Pain - Bladder	Renal and urinary disorders	Arm II: Placebo	23	174

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I: Gemcitabine	17	201
Total, all-cause mortality	Arm II: Placebo	25	205
Total, other adverse events	Arm I: Gemcitabine	60	165
Total, other adverse events	Arm II: Placebo	58	174
Total, serious adverse events	Arm I: Gemcitabine	7	165
Total, serious adverse events	Arm II: Placebo	5	174

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29801011	DERIVED	PubMed
35871040	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA032102	Southwest Oncology Group Treatment Grant	BLANKE, CHARLES D.	OREGON HEALTH & SCIENCE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I: Gemcitabine vs Arm II: Placebo: deaths from any cause	Trial comparisons
Arm I: Gemcitabine vs Arm II: Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00445601

GET https://conductscience.org/api/trials/v1/NCT00445601/events?page=2

API reference For AI assistants