Trial · NCT00234039
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
NCT00234039, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2012-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin. Trials, record NCT00234039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00234039
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
- NCT number
- NCT00234039
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Bladder Cancer
- Interventions
- gemcitabine hydrochloride
- First posted
- 2005-10-06
- Last updated
- 2016-01-08
- Results first posted
- 2012-12-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate at the End of Induction | Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 | Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy |
| Secondary | Overall Survival (OS) | 1 year | Measured from the day of registration to death due to any cause. Survival is censored at date of last contact. |
| Secondary | Recurrence-free Survival (RFS) | 1 year | Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause. |
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Survival (OS) | 1 year | All eligible patients who started treatment were included in the analysis | percentage of participants | NUMBER |
| PRIMARY | Complete Response Rate at the End of Induction | Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 | All eligible patients who started treatment were included in the analysis | percentage of participants | NUMBER |
| SECONDARY | Recurrence-free Survival (RFS) | 1 year | All eligible patients who started treatment were included in the analysis | percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks | Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Intravesical Gemcitabine | 98 | percentage of participants | ||
| Complete Response Rate at the End of Induction | Intravesical Gemcitabine | 46 | 95% Confidence Interval 30 to 60 | percentage of participants | |
| Recurrence-free Survival (RFS) | Intravesical Gemcitabine | 28 | 95% Confidence Interval 16 to 43 | percentage of participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Intravesical Gemcitabine | Neutrophils/granulocytes (ANC/AGC) | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Intravesical Gemcitabine | Pain - Bladder | 1 | Participants | |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Intravesical Gemcitabine | Urinary frequency/urgency | 2 | Participants |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravesical Gemcitabine | 58 | |
| Overall Study | Eligible | Intravesical Gemcitabine | 49 | |
| Overall Study | Eligible and Began Protocol Therapy | Intravesical Gemcitabine | 47 | |
| Overall Study | COMPLETED | Intravesical Gemcitabine | 8 | |
| Overall Study | NOT COMPLETED | Intravesical Gemcitabine | 50 |
Source ClinicalTrials.gov
Adverse events12
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 | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | Intravesical Gemcitabine | 3 | 47 | |
| other | Constipation | Gastrointestinal disorders | Intravesical Gemcitabine | 3 | 47 | |
| other | Nausea | Gastrointestinal disorders | Intravesical Gemcitabine | 4 | 47 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Intravesical Gemcitabine | 9 | 47 | |
| other | Pain-Other (Specify) | General disorders | Intravesical Gemcitabine | 3 | 47 | |
| other | Platelets | Investigations | Intravesical Gemcitabine | 3 | 47 | |
| other | Dizziness | Nervous system disorders | Intravesical Gemcitabine | 3 | 47 | |
| other | Bladder spasms | Renal and urinary disorders | Intravesical Gemcitabine | 8 | 47 | |
| other | Hemorrhage, GU - Urinary NOS | Renal and urinary disorders | Intravesical Gemcitabine | 7 | 47 | |
| other | Pain - Bladder | Renal and urinary disorders | Intravesical Gemcitabine | 14 | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intravesical Gemcitabine | ||
| Total, other adverse events | Intravesical Gemcitabine | 32 | 47 |
| Total, serious adverse events | Intravesical Gemcitabine | 0 | 47 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT00234039
GET https://conductscience.org/api/trials/v1/NCT00234039/registered