Trial · NCT00238420

Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

NCT00238420, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer. Trials, record NCT00238420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00238420

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Trial

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

Title: Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer
NCT number: NCT00238420
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 70 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v6 and v7, Stage II Bladder Cancer AJCC v6 and v7, Stage III Bladder Cancer AJCC v6 and v7
Interventions: Paclitaxel, Radiation Therapy, Trastuzumab
First posted: 2005-10-13
Last updated: 2022-07-19
Results first posted: 2016-05-23
Limitations and caveats: Accrual of patients with her2/neu overexpression stopped early due to unmet targeted accrual goals, with 22 subject accrued out of 40 planned.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Acute Treatment-related Toxicity	From start of protocol treatment to 90 days	In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: ≥ gr4 neutropenia, ≥ gr4 febrile neutropenia, ≥ gr3 diarrhea, ≥ gr3 nausea/vomiting, ≥ gr3 thrombocytopenia, ≥ gr3 renal, pulmonary, hepatic, or neurologic toxicity, ≥ gr3 rectal or genitourinary bleeding, ≥ gr3 left ventricular failure, or ≥ gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis.
Secondary	Treatment Completion	From registration to end of treatment; up to 64 days."	The number of patients within each group who completed all elements of protocol treatment are reported.
Secondary	Complete Response to Treatment	At 12 weeks from treatment start	The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment.
Secondary	Progression-free Survival	From start of treatment to last follow-up. Maximum follow-up at time of analysis was 9.9 years.	Disease (failure) is defined as any bladder cancer progression determined by all measures of disease including physical exam, imaging, and biopsies. Disease-free survival time is defined as time from treatment start to the date of first progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared.
Secondary	Overall Survival	From the date of treatment started to death, assessed up to at least 5 years	Overall survival time is defined as time from treatment start to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Acute Treatment-related Toxicity	From start of protocol treatment to 90 days	All eligible patients who started study treatment	participants	NUMBER
SECONDARY	Treatment Completion	From registration to end of treatment; up to 64 days.	All eligible patients who started study treatment	participants	NUMBER
SECONDARY	Complete Response to Treatment	At 12 weeks from treatment start	All eligible patients who started treatment and had an evaluation to assess response by 12 weeks	percentage of participants	NUMBER
SECONDARY	Progression-free Survival	From start of treatment to last follow-up. Maximum follow-up at time of analysis was 9.9 years.	Eligible participants who started treatment. (This population changed since the initial analysis: 3 participants first thought to be eligible were later determined to be ineligible.)	years	MEDIAN
SECONDARY	Overall Survival	From the date of treatment started to death, assessed up to at least 5 years	Eligible participants who started treatment. (This population changed since the initial analysis: 3 participants first thought to be eligible were later determined to be ineligible.)	years	MEDIAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Acute Treatment-related Toxicity	HER2+ :RT, Paclitaxel, and Trastuzumab	7		participants
Acute Treatment-related Toxicity	HER2- :RT and Paclitaxel	14		participants
Treatment Completion	HER2+ :RT, Paclitaxel, and Trastuzumab	13		participants
Treatment Completion	HER2- :RT and Paclitaxel	34		participants
Complete Response to Treatment	HER2+ :RT, Paclitaxel, and Trastuzumab	61.5	95% Confidence Interval 31.6 to 86.1	percentage of participants
Complete Response to Treatment	HER2- :RT and Paclitaxel	57.6	95% Confidence Interval 39.2 to 74.5	percentage of participants
Progression-free Survival	HER2+ :RT, Paclitaxel, and Trastuzumab	1.1	95% Confidence Interval 0.6 to 2.8	years
Progression-free Survival	HER2- :RT and Paclitaxel	0.8	95% Confidence Interval 0.4 to 3.0	years
Overall Survival	HER2+ :RT, Paclitaxel, and Trastuzumab	2.8	95% Confidence Interval 1.1 to 4.4	years
Overall Survival	HER2- :RT and Paclitaxel	2.0	95% Confidence Interval 1.1 to 8.5	years

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	HER2+ :RT, Paclitaxel, and Trastuzumab	22
Overall Study	STARTED	HER2- :RT and Paclitaxel	48
Overall Study	COMPLETED	HER2+ :RT, Paclitaxel, and Trastuzumab	21
Overall Study	COMPLETED	HER2- :RT and Paclitaxel	47
Overall Study	NOT COMPLETED	HER2+ :RT, Paclitaxel, and Trastuzumab	1
Overall Study	NOT COMPLETED	HER2- :RT and Paclitaxel	1

Source ClinicalTrials.gov

Adverse events214

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	Blood/bone marrow - Other	Blood and lymphatic system disorders	HER2+ :RT, Paclitaxel, and Trastuzumab	3	21
other	Blood/bone marrow - Other	Blood and lymphatic system disorders	HER2- :RT and Paclitaxel	3	47
other	Hemoglobin	Blood and lymphatic system disorders	HER2+ :RT, Paclitaxel, and Trastuzumab	15	21
other	Hemoglobin	Blood and lymphatic system disorders	HER2- :RT and Paclitaxel	25	47
other	Atrial fibrillation	Cardiac disorders	HER2+ :RT, Paclitaxel, and Trastuzumab	2	21
other	Atrial fibrillation	Cardiac disorders	HER2- :RT and Paclitaxel	1	47
other	Abdominal pain NOS	Gastrointestinal disorders	HER2+ :RT, Paclitaxel, and Trastuzumab	2	21
other	Abdominal pain NOS	Gastrointestinal disorders	HER2- :RT and Paclitaxel	7	47
other	Constipation	Gastrointestinal disorders	HER2+ :RT, Paclitaxel, and Trastuzumab	4	21
other	Constipation	Gastrointestinal disorders	HER2- :RT and Paclitaxel	12	47

1 to 10 of 214Source ClinicalTrials.gov

See all 214 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HER2+ :RT, Paclitaxel, and Trastuzumab
Total, all-cause mortality	HER2- :RT and Paclitaxel
Total, other adverse events	HER2+ :RT, Paclitaxel, and Trastuzumab	20	21
Total, other adverse events	HER2- :RT and Paclitaxel	46	47
Total, serious adverse events	HER2+ :RT, Paclitaxel, and Trastuzumab	6	21
Total, serious adverse events	HER2- :RT and Paclitaxel	15	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37442672	DERIVED

Source PubMed

Grants2

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	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA021661	Radiation Therapy Oncology Group	CURRAN, WALTER J.	AMERICAN COLLEGE OF RADIOLOGY	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons3

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

Comparison	Source
HER2+ :RT, Paclitaxel, and Trastuzumab vs HER2- :RT and Paclitaxel: Acute Treatment-related Toxicity	Trial comparisons
HER2+ :RT, Paclitaxel, and Trastuzumab vs HER2- :RT and Paclitaxel: Treatment Completion	Trial comparisons
HER2+ :RT, Paclitaxel, and Trastuzumab vs HER2- :RT and Paclitaxel: 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/NCT00238420

GET https://conductscience.org/api/trials/v1/NCT00238420/events?page=2

API reference For AI assistants