Trial Outcomes & Findings for Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer (NCT NCT02316548)

Last Updated: 2025-11-20

Results Overview

PRFS is defined as time free of pelvic recurrence or death, with patients who experience distant metastasis censored at the time of occurrence. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. PRFS was to be tested between arms in terms of a difference in cause-specific-hazards using the log-rank test and cumulative incidence of PRFS in the presence of competing risks was to be computed via cumulative incidence. Due to early termination with few patients, only counts of events have been calculated.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

Results posted on

2025-11-20

Participant Flow

Fourteen patient were screened. One patients did not continue to randomization due to disease progression and was not followed further.

Participant milestones

Participant milestones
Measure	No Radiation Therapy Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Overall Study STARTED	6	7
Overall Study Eligible Population	6	6
Overall Study Eligible With Disease Assessment	4	1
Overall Study Eligible With Adverse Event Data	4	2
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	No Radiation Therapy Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Overall Study Protocol Violation	0	1

Baseline Characteristics

Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Radiation Therapy n=6 Participants Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) n=6 Participants Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.	Total n=12 Participants Total of all reporting groups
Age, Continuous	67 years	67 years n=4 Participants	67 years n=8 Participants
Sex: Female, Male Female	6 Participants	3 Participants n=4 Participants	9 Participants n=8 Participants
Sex: Female, Male Male	0 Participants	3 Participants n=4 Participants	3 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants	6 Participants n=4 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	6 Participants	5 Participants n=4 Participants	11 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Chemotherapy Neoadjuvant or adjuvant chemotherapy	5 Participants	4 Participants n=4 Participants	9 Participants n=8 Participants
Chemotherapy No chemotherapy	1 Participants	2 Participants n=4 Participants	3 Participants n=8 Participants
Pelvic Relapse Risk Category Intermediate Risk	3 Participants	3 Participants n=4 Participants	6 Participants n=8 Participants
Pelvic Relapse Risk Category High Risk	3 Participants	3 Participants n=4 Participants	6 Participants n=8 Participants
Zubrod performance status 0	2 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants
Zubrod performance status 1	2 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants
Zubrod performance status 2	2 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants
N Stage N2	1 Participants	1 Participants n=4 Participants	2 Participants n=8 Participants
T Stage T3a	2 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants
T Stage T3b	3 Participants	2 Participants n=4 Participants	5 Participants n=8 Participants
T Stage T4a	1 Participants	3 Participants n=4 Participants	4 Participants n=8 Participants
T Stage T4b	0 Participants	1 Participants n=4 Participants	1 Participants n=8 Participants
N Stage N0	3 Participants	2 Participants n=4 Participants	5 Participants n=8 Participants
N Stage N1	2 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants

PRIMARY outcome

Timeframe: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

Population: Randomized eligible patients with disease assessment data

Outcome measures

Outcome measures
Measure	No Radiation Therapy n=4 Participants Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) n=1 Participants Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Pelvic Recurrence-free Survival (PRFS)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

Population: Randomized eligible patients with disease assessment data

Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death and was to be estimated by the Kaplan-Meier method and arms compared using the log-rank test. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. Distant metastases is defined as any hematogenous metastases and/or lymph node metastases above the L5-S1 interspace, documented by imaging (CT and/or MRI and/or bone scans). Due to early termination with few patients, only counts of events have been calculated.

Outcome measures

Outcome measures
Measure	No Radiation Therapy n=4 Participants Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) n=1 Participants Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Disease Free Survival (DFS)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months

Population: Randomized eligible patients with adverse event data

Adverse events (AE) evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Bowel toxicity= abdominal distension/pain, colitis, colonic fistula/ hemorrhage/obstruction/perforation/stenosis/ulcer, diarrhea, enterocolitis, fecal incontinence/gastrointestinal/fistula/pain, ileal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, Ileus, jejunal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, lower gastrointestinal hemorrhage, rectal fistula/hemorrhage/mucositis/necrosis/obstruction/pain/perforation/stenosis/ulcer, small intestinal mucositis/obstruction/perforation/stenosis/ulcer, vomiting. Highest grade adverse event per subject counted. Grade refers to AE severity and ranges from 1 to 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1 Mild, 2 Moderate, 3 Severe, 4 Life-threatening or disabling, 5 Death related to AE.

Outcome measures

Outcome measures
Measure	No Radiation Therapy n=4 Participants Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) n=2 Participants Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Number of Patients With Bowel Toxicity None	2 Participants	0 Participants
Number of Patients With Bowel Toxicity Grade 1	2 Participants	1 Participants
Number of Patients With Bowel Toxicity Grade 2	0 Participants	0 Participants
Number of Patients With Bowel Toxicity Grade 4	0 Participants	0 Participants
Number of Patients With Bowel Toxicity Grade 5	0 Participants	0 Participants
Number of Patients With Bowel Toxicity Grade 3	0 Participants	1 Participants

Adverse Events

No Radiation Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Intensity-modulated Radiation Therapy (IMRT)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	No Radiation Therapy n=4 participants at risk Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) n=2 participants at risk Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Gastrointestinal disorders Rectal fistula	0.00% 0/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Infections and infestations Pelvic infection	0.00% 0/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.

Other adverse events

Other adverse events
Measure	No Radiation Therapy n=4 participants at risk Patients do not receive radiation therapy (RT).	Intensity-modulated Radiation Therapy (IMRT) n=2 participants at risk Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	100.0% 2/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Gastrointestinal disorders Constipation	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	0.00% 0/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Gastrointestinal disorders Gastrointestinal pain	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	0.00% 0/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
General disorders Edema limbs	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	0.00% 0/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Infections and infestations Urinary tract infection	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	50.0% 1/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	0.00% 0/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.
Nervous system disorders Paresthesia	25.0% 1/4 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.	0.00% 0/2 • From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months. Randomized eligible patients with adverse event data are included in the adverse event tables. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. All randomized eligible patients are include in the mortality table.

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER