Trial · NCT00055601

Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer

NCT00055601, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2016-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer. Trials, record NCT00055601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00055601

On this page

Trial

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

Title: Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer
NCT number: NCT00055601
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: Radiation Therapy Oncology Group
Conditions: Bladder Cancer
Interventions: cisplatin, fluorouracil, paclitaxel, radiation therapy, Gemcitabine, Radical cystectomy
First posted: 2003-03-07
Last updated: 2018-06-15
Results first posted: 2016-08-10

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Treatment Completion Rate	From randomization to 11 weeks	Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction.
Secondary	Complete Response After Induction	From randomization to eight weeks	Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass.
Secondary	Bladder-intact Survival Rate (5 Years)	From the date of randomization to five years.	Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Completion Rate	From randomization to 11 weeks	All eligible patients who started study treatment.	percentage of participants	NUMBER
SECONDARY	Complete Response After Induction	From randomization to eight weeks	All eligible patients who started study treatment	percentage of participants	NUMBER
SECONDARY	Bladder-intact Survival Rate (5 Years)	From the date of randomization to five years.	All eligible patients who started study treatment	percentage of 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	Value	Spread	Units
Treatment Completion Rate	Pelvic RT + Paclitaxel + Cisplatin	67	95% Confidence Interval 51 to 80	percentage of participants
Treatment Completion Rate	Pelvic RT + Fluorouracil + Cisplatin	53	95% Confidence Interval 38 to 68	percentage of participants
Complete Response After Induction	Pelvic RT + Paclitaxel + Cisplatin	72	95% Confidence Interval 57 to 84	percentage of participants
Complete Response After Induction	Pelvic RT + Fluorouracil + Cisplatin	62	95% Confidence Interval 46 to 76	percentage of participants
Bladder-intact Survival Rate (5 Years)	Pelvic RT + Paclitaxel + Cisplatin	67	95% Confidence Interval 53 to 81	percentage of participants
Bladder-intact Survival Rate (5 Years)	Pelvic RT + Fluorouracil + Cisplatin	71	95% Confidence Interval 57 to 84	percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pelvic RT + Paclitaxel + Cisplatin	48
Overall Study	STARTED	Pelvic RT + Fluorouracil + Cisplatin	49
Overall Study	COMPLETED	Pelvic RT + Paclitaxel + Cisplatin	46
Overall Study	COMPLETED	Pelvic RT + Fluorouracil + Cisplatin	47
Overall Study	NOT COMPLETED	Pelvic RT + Paclitaxel + Cisplatin	2
Overall Study	NOT COMPLETED	Pelvic RT + Fluorouracil + Cisplatin	2

Source ClinicalTrials.gov

Adverse events296

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	Hematologic-Other	Blood and lymphatic system disorders	Pelvic RT + Paclitaxel + Cisplatin	26	46
other	Hematologic-Other	Blood and lymphatic system disorders	Pelvic RT + Fluorouracil + Cisplatin	19	47
other	Hemoglobin decreased	Blood and lymphatic system disorders	Pelvic RT + Paclitaxel + Cisplatin	43	46
other	Hemoglobin decreased	Blood and lymphatic system disorders	Pelvic RT + Fluorouracil + Cisplatin	43	47
other	Hemolysis NOS	Blood and lymphatic system disorders	Pelvic RT + Paclitaxel + Cisplatin	3	46
other	Hemolysis NOS	Blood and lymphatic system disorders	Pelvic RT + Fluorouracil + Cisplatin	1	47
other	Circulatory or cardiac-Other	Cardiac disorders	Pelvic RT + Paclitaxel + Cisplatin	4	46
other	Circulatory or cardiac-Other	Cardiac disorders	Pelvic RT + Fluorouracil + Cisplatin	1	47
other	Edema NOS	Cardiac disorders	Pelvic RT + Paclitaxel + Cisplatin	7	46
other	Edema NOS	Cardiac disorders	Pelvic RT + Fluorouracil + Cisplatin	7	47

1 to 10 of 296Source ClinicalTrials.gov

See all 296 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pelvic RT + Paclitaxel + Cisplatin
Total, all-cause mortality	Pelvic RT + Fluorouracil + Cisplatin
Total, other adverse events	Pelvic RT + Paclitaxel + Cisplatin	46	46
Total, other adverse events	Pelvic RT + Fluorouracil + Cisplatin	47	47
Total, serious adverse events	Pelvic RT + Paclitaxel + Cisplatin	43	46
Total, serious adverse events	Pelvic RT + Fluorouracil + Cisplatin	39	47

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23823157	DERIVED	PubMed
25366678	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Pelvic RT + Paclitaxel + Cisplatin vs Pelvic RT + Fluorouracil + Cisplatin: serious adverse events

Source 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/NCT00055601

GET https://conductscience.org/api/trials/v1/NCT00055601/events?page=2

API reference For AI assistants