Trial · NCT00005047

4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer

NCT00005047, Phase 3, Terminated, SWOG Cancer Research Network; results first posted 2017-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer. Trials, record NCT00005047. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005047

On this page

Trial

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

Title: 4B951, Combination Chemotherapy in Treating Patients With Bladder Cancer
NCT number: NCT00005047
Status: Terminated
Phases: Phase 3
Enrollment: 521 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Bladder Cancer
Interventions: cisplatin, doxorubicin hydrochloride, methotrexate, vinblastine
First posted: 2003-01-27
Last updated: 2017-06-08
Results first posted: 2017-06-08

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Probability of Recurring	5 years	p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Time from registration to the first observation of disease recurrence, censoring patients who died of unrelated causes. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.
Secondary	Probability of Overall Survival	5 years	p53 positive patients randomized to MVAC (arm I) compared to p53 positive patients randomized to observation (arm II). Survival is calculated from registration to death due to any cause. Probabilities of survival were based on the Kaplan-Meier product-limit method.
Secondary	Probability of Recurrence	5 years	Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of recurring were based on cumulative incidence curves. Recurrence is defined as first radiological appearance of bladder cancer, per local standard of care.
Secondary	Probability of Overall Survival	5 years	Patients with tumors demonstrating alteration in p53 compared to patients with no p53 alterations. Probabilities of survival were based on the Kaplan-Meier product-limit method.

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	Probability of Recurring	5 years		probability	MEDIAN
SECONDARY	Probability of Overall Survival	5 years		probability	MEDIAN
SECONDARY	Probability of Recurrence	5 years	This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).	probability	MEDIAN
SECONDARY	Probability of Overall Survival	5 years	This analysis compares p53 positive patients (combined arms I, II, and IV) to p53 negative patients (arm III).	probability	MEDIAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Probability of Recurring	Arm I: M-VAC x 3	0.85	Standard Error 0.05	probability
Probability of Recurring	Arm II: Observation	0.84	Standard Error 0.06	probability
Probability of Overall Survival	Arm I: M-VAC x 3	0.87	Standard Error 0.05	probability
Probability of Overall Survival	Arm II: Observation	0.84	Standard Error 0.05	probability
Probability of Recurrence	p53 Positive Patients	0.83	Standard Error 0.03	probability
Probability of Recurrence	p53 Negative Patients	0.77	Standard Error 0.03	probability
Probability of Overall Survival	p53 Positive Patients	0.82	Standard Error 0.03	probability
Probability of Overall Survival	p53 Negative Patients	0.84	Standard Error 0.03	probability

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I: M-VAC x 3	58
Overall Study	STARTED	Arm II: Observation	56
Overall Study	STARTED	Arm III: Observation	227
Overall Study	STARTED	Arm IV: Observation	158
Overall Study	COMPLETED	Arm I: M-VAC x 3	39
Overall Study	COMPLETED	Arm II: Observation	56
Overall Study	COMPLETED	Arm III: Observation	227
Overall Study	COMPLETED	Arm IV: Observation	158
Overall Study	NOT COMPLETED	Arm I: M-VAC x 3	19
Overall Study	NOT COMPLETED	Arm II: Observation	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

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	Decreased WBC	Blood and lymphatic system disorders	Arm I: M-VAC x 3	14	46
other	Decreased WBC	Blood and lymphatic system disorders	Arm II: Observation	0	0	0
other	Decreased WBC	Blood and lymphatic system disorders	Arm III: Observation	0	0	0
other	Decreased WBC	Blood and lymphatic system disorders	Arm IV: Observation	0	0	0
other	Fatigue	General disorders	Arm I: M-VAC x 3	6	46
other	Fatigue	General disorders	Arm II: Observation	0	0	0
other	Fatigue	General disorders	Arm III: Observation	0	0	0
other	Fatigue	General disorders	Arm IV: Observation	0	0	0
other	Lymphopenia	Blood and lymphatic system disorders	Arm I: M-VAC x 3	4	46
other	Lymphopenia	Blood and lymphatic system disorders	Arm II: Observation	0	0	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I: M-VAC x 3	12	58
Total, all-cause mortality	Arm II: Observation	9	56
Total, all-cause mortality	Arm III: Observation	41	227
Total, all-cause mortality	Arm IV: Observation	36	158
Total, other adverse events	Arm I: M-VAC x 3	35	46
Total, other adverse events	Arm II: Observation	0	0
Total, other adverse events	Arm III: Observation	0	0
Total, other adverse events	Arm IV: Observation	0	0
Total, serious adverse events	Arm I: M-VAC x 3	0	46
Total, serious adverse events	Arm II: Observation	0	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25413313	DERIVED

Source 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 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.

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/NCT00005047

GET https://conductscience.org/api/trials/v1/NCT00005047/events?page=2

API reference For AI assistants