A Phase 2 interventional study of Intensity-Modulated Radiation Therapy in Stage III Bladder Cancer and Stage IV Bladder Cancer, sponsored by NRG Oncology. Terminated at 127 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by NRG Oncology · Phase 2, Interventional, and Treatment
This randomized phase II trial studies the side effects and how well postoperative intensity modulated radiotherapy works after surgery in treating patients with urothelial bladder cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more effective than surgery alone in treating patients with urothelial bladder cancer.
PRIMARY OBJECTIVE:
I. To evaluate the ability of postcystectomy adjuvant radiotherapy to safely reduce pelvic tumor recurrence, defined as pelvic recurrence-free survival.
SECONDARY OBJECTIVES:
I. Evaluate increase in disease-free survival. II. Evaluate toxicity of adjuvant pelvic radiotherapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients are stratified by neoadjuvant preoperative or postoperative adjuvant chemotherapy.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
1,617 studies on the registry are indexed under Urinary Bladder Neoplasms; 422 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →NRG Oncology is the lead sponsor of 72 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (A patient cannot be considered eligible for this study unless ALL of the following conditions are met.):
Patients must have undergone a radical cystectomy (reconstructed urinary diversion may be non-continent diversions (eg, ileal conduits) or continent non-orthotopic catheterizable diversions (eg, Indiana pouch) or continent orthotopic diversions (eg, Studer pouch or neobladder)for urothelial bladder carcinoma within 105 days prior to registration. Final cystectomy pathology must be either pure urothelial carcinoma or dominant urothelial carcinoma with admixture of other histologies excluding small cell variants.
Patients with the following pTNM stages per the American Joint Committee on Cancer (AJCC) 7th ed. are eligible:
Appropriate stage for study entry based on the following diagnostic workup:
Complete blood count (CBC)/differential obtained ≤ 14 days prior to registration with adequate bone marrow function defined as follows:
Exclusion Criteria (Patients with any of the following conditions are NOT eligible for this study.):
Severe, active co-morbidity defined as follows:
Patients do not receive radiation therapy (RT).
Postoperative adjuvant intensity-modulated radiation therapy (IMRT).
Radiation: Intensity-Modulated Radiation Therapy
Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions. In patients not getting postoperative adjuvant chemotherapy the radiation treatment must begin within 140 days after cystectomy. For patients getting adjuvant chemotherapy radiation treatment must start within 49 days of completing chemotherapy.
Also known as: IMRT
Pelvic Recurrence-free Survival (PRFS)
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.
Time frame: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months
Disease Free Survival (DFS)
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.
Time frame: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months
Number of Patients With Bowel Toxicity
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.
Time frame: From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months
| Milestone | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) |
|---|---|---|
| Started | 6 | 7 |
| Eligible population | 6 | 6 |
| Eligible with disease assessment | 4 | 1 |
| Eligible with adverse event data | 4 | 2 |
| Completed | 6 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| Participants | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) |
|---|---|---|
| Pelvic Recurrence-free Survival (PRFS) | 1 | 0 |
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.
| Participants | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) |
|---|---|---|
| Disease Free Survival (DFS) | 2 | 1 |
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.
| Participants | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) |
|---|---|---|
| None | 2 | 0 |
| Grade 1 | 2 | 1 |
| Grade 2 | 0 | 0 |
| Grade 3 | 0 | 1 |
| Grade 4 | 0 | 0 |
| Grade 5 | 0 | 0 |
Collected over From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Radiation Therapy | 1/6 (16.7%) | 0/4 (0%) | 3/4 (75%) |
| Intensity-modulated Radiation Therapy (IMRT) | 1/7 (14.3%) | 1/2 (50%) | 2/2 (100%) |
| Event | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) |
|---|---|---|
| DiarrheaGastrointestinal disorders | 0/4 | 1/2 |
| Rectal fistulaGastrointestinal disorders | 0/4 | 1/2 |
| Pelvic infectionInfections and infestations | 0/4 | 1/2 |
| HyponatremiaMetabolism and nutrition disorders | 0/4 | 1/2 |
| Acute kidney injuryRenal and urinary disorders | 0/4 | 1/2 |
| Event | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) |
|---|---|---|
| Abdominal painGastrointestinal disorders | 1/4 | 2/2 |
| AnemiaBlood and lymphatic system disorders | 1/4 | 1/2 |
| ConstipationGastrointestinal disorders | 1/4 | 1/2 |
| Urinary tract infectionInfections and infestations | 1/4 | 1/2 |
| DiarrheaGastrointestinal disorders | 1/4 | 0/2 |
| Gastrointestinal painGastrointestinal disorders | 1/4 | 0/2 |
| Edema limbsGeneral disorders and administration site conditions | 1/4 | 0/2 |
| Back painMusculoskeletal and connective tissue disorders | 1/4 | 0/2 |
| ParesthesiaNervous system disorders | 1/4 | 0/2 |
Randomized eligible patients
| Age, Continuous(years) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| Median | 67 (60 to 77) | 67 (37 to 82) | 67 (37 to 82) |
| Sex: Female, Male(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 0 | 3 | 3 |
| Ethnicity (NIH/OMB)(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 6 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 6 | 5 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Chemotherapy(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| Neoadjuvant or adjuvant chemotherapy | 5 | 4 | 9 |
| No chemotherapy | 1 | 2 | 3 |
| Pelvic Relapse Risk Category(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| Intermediate Risk | 3 | 3 | 6 |
| High Risk | 3 | 3 | 6 |
| Zubrod performance status(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| 0 | 2 | 3 | 5 |
| 1 | 2 | 3 | 5 |
| 2 | 2 | 0 | 2 |
| T Stage(Participants) | No Radiation Therapy | Intensity-modulated Radiation Therapy (IMRT) | Total |
|---|---|---|---|
| T3a | 2 | 0 | 2 |
| T3b | 3 | 2 | 5 |
| T4a | 1 | 3 | 4 |
| T4b | 0 | 1 | 1 |
1 further baseline measures are reported on the registry.
Showing the first 100 of 127 sites across 3 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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