Trial · NCT00981656

Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer

NCT00981656, Phase 2, Completed, Radiation Therapy Oncology Group; results first posted 2022-04-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer. Trials, record NCT00981656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00981656

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Trial

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

Title: Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer
NCT number: NCT00981656
Status: Completed
Phases: Phase 2
Enrollment: 37 participants, actual
Lead sponsor: Radiation Therapy Oncology Group
Conditions: Bladder Cancer
Interventions: cisplatin, 5-fluorouracil, Mitomycin, Three-Dimensional Conformal Radiation Therapy
First posted: 2009-09-22
Last updated: 2024-09-19
Results first posted: 2022-04-25

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Free From Radical Cystectomy at 3 Years	Three years from registration	The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.
Secondary	Percentage of Participants Free From Radical Cystectomy at 5 Years	Five years from registration	The number of participants who did not undergo a radical cystectomy within five years divided by the number of analyzed participants.
Secondary	Percent of Participants With Distant Disease Progression at 3 Years	From registration to three years	Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.
Secondary	Percent of Participants With Distant Disease Progression at 5 Years	From registration to five years	Distant disease progression is defined as the first appearance of disease in a non-regional lymph node, solid organ or bone. Time to distant disease progression is defined as time from registration to the date of first distant disease progression, last known follow-up (censored), or death without distant disease progression (competing risk). Distant disease progression rate is estimated using the cumulative incidence method.
Secondary	Percentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years	From registration to three years	Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rates was to be estimated using the cumulative incidence method.
Secondary	Percentage of Participants With Progression to Tumor Stage T2 or Greater at 5 Years	From registration to five years	Primary tumor stage T2 = tumor invades muscle; T3 = tumor invades perivesical tissue; T4 = tumor invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall. Time to progression is defined as time from registration to the date of first progression, last known follow-up (censored), or death without tumor progression (competing risk). Tumor progression rate was to be estimated using the cumulative incidence method.
Secondary	Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)	From registration to five years	Time to death from bladder cancer is defined as time from registration to death from bladder cancer, last known follow-up (censored), or death from other cause (competing risk). More specifically, death absent a distant metastasis, death from non-bladder cancer, and death absent local recurrence comprise the competing risk. Death from bladder cancer rate is estimated using the cumulative incidence method.
Secondary	Percentage of Participants Alive at 3 Years	From registration to three years	Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Secondary	Percentage of Participants Alive at 5 Years	From registration to five years	Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.
Secondary	Distribution of Participants by Highest Grade Adverse Event	Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.	Common Terminology Criteria for Adverse Events (CTCAE) version 4 grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Free From Radical Cystectomy at 3 Years	Three years from registration	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Free From Radical Cystectomy at 5 Years	Five years from registration	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Percent of Participants With Distant Disease Progression at 3 Years	From registration to three years	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Percent of Participants With Distant Disease Progression at 5 Years	From registration to five years	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years	From registration to three years	T-stage was not collected on follow-up forms and therefore this outcome measure could not be not analyzed.
SECONDARY	Percentage of Participants With Progression to Tumor Stage T2 or Greater at 5 Years	From registration to five years	T-stage was not collected on follow-up forms and therefore this outcome measure cab not be not analyzed.
SECONDARY	Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)	From registration to five years	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Alive at 3 Years	From registration to three years	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Alive at 5 Years	From registration to five years	Eligible participants who started study treatment	percentage of participants	NUMBER
SECONDARY	Distribution of Participants by Highest Grade Adverse Event	Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.	Eligible participants who started study treatment	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group15

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Free From Radical Cystectomy at 3 Years	3DCRT + CT		88.2	97.5% Confidence Interval 72.5 to NA	percentage of participants
Percentage of Participants Free From Radical Cystectomy at 5 Years	3DCRT + CT		88.2	95% Confidence Interval 72.5 to 96.7	percentage of participants
Percent of Participants With Distant Disease Progression at 3 Years	3DCRT + CT		12.3	95% Confidence Interval 3.8 to 26.3	percentage of participants
Percent of Participants With Distant Disease Progression at 5 Years	3DCRT + CT		18.7	95% Confidence Interval 7.4 to 34.0	percentage of participants
Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)	3DCRT + CT		25.1	95% Confidence Interval 11.5 to 41.3	percentage of participants
Percentage of Participants Alive at 3 Years	3DCRT + CT		69.2	95% Confidence Interval 53.3 to 85.2	percentage of participants
Percentage of Participants Alive at 5 Years	3DCRT + CT		56.4	95% Confidence Interval 39.1 to 73.7	percentage of participants
Distribution of Participants by Highest Grade Adverse Event	3DCRT + CT	Grade 1	2		Participants
Distribution of Participants by Highest Grade Adverse Event	3DCRT + CT	Grade 2	9		Participants
Distribution of Participants by Highest Grade Adverse Event	3DCRT + CT	Grade 3	20		Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow4

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

Period	Milestone	Group	Participants
Overall Study	STARTED	3DCRT + CT	37
Overall Study	Eligible and Started Study Treatment	3DCRT + CT	34
Overall Study	COMPLETED	3DCRT + CT	34
Overall Study	NOT COMPLETED	3DCRT + CT	3

Source ClinicalTrials.gov

Adverse events98

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	Anemia	Blood and lymphatic system disorders	3DCRT + CT	20	34
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	3DCRT + CT	2	34
other	Abdominal distension	Gastrointestinal disorders	3DCRT + CT	2	34
other	Abdominal pain	Gastrointestinal disorders	3DCRT + CT	4	34
other	Constipation	Gastrointestinal disorders	3DCRT + CT	17	34
other	Diarrhea	Gastrointestinal disorders	3DCRT + CT	21	34
other	Dyspepsia	Gastrointestinal disorders	3DCRT + CT	3	34
other	Dysphagia	Gastrointestinal disorders	3DCRT + CT	2	34
other	Flatulence	Gastrointestinal disorders	3DCRT + CT	5	34
other	Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	3DCRT + CT	6	34

1 to 10 of 98Source ClinicalTrials.gov

See all 98 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	3DCRT + CT	15	34
Total, other adverse events	3DCRT + CT	33	34
Total, serious adverse events	3DCRT + CT	7	34

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39226514	DERIVED

Source 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 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/NCT00981656

GET https://conductscience.org/api/trials/v1/NCT00981656/events?page=2

API reference For AI assistants